Fetal ConditionsNCT06056635
A Prospective Study on the Role of Karl Storz Curved and Straight Fetoscopes (11508AAK and 11506AAK) for Fetoscopic Intrauterine Procedures
A study testing Karl Storz Curved Scope and Karl Storz Straight Scope in people with Fetal Conditions and Maternal; Procedure, run by Boston Children's Hospital at 1 site in United States.
Trial summary
In this research study, the investigators want to learn more about the role of new innovative surgical devices, the Karl Storz Curved and Straight Fetoscopes for in-utero surgery. A fetoscope is like a small telescope that can see inside of the uterus (womb) during minimally invasive surgery. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Fetal Conditions, Maternal; Procedure, Pregnancy Related
- What is being tested?
- Karl Storz Curved Scope and Karl Storz Straight Scope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2024to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant patient with a condition requiring in-utero surgery
- Patient must be eligible for anesthesia
- Patient and father of the fetus (if available) are able to provide signed informed consent
Who cannot join
- Allergy or previous adverse reaction to any ancillary medication specified in this protocol that has no alternative
- Preterm labor, preeclampsia, or uterine anomaly (e.g., large fibroid tumor) in the index pregnancy
- Suspicion of major recognized congenital syndrome on ultrasound or MRI that is not compatible with postnatal life
- Pre-pregnancy maternal BMI greater than 40
- High risk for fetal hemophilia
- Fetal aneuploidy or variants of known significance if an amniocentesis was performed
- Contraindication to abdominal surgery or fetoscopic surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Brittany Gudanowski, 617-919-6658, Brittany.Gudanowski@childrens.harvard.edu
Fetal Care and Surgery Center, 617-355-6512, MFCCFetalResearchStudies-dl@childrens.harvard.edu
About this study
In this research study, the investigators want to learn more about the role of new innovative surgical devices, the Karl Storz Curved and Straight Fetoscopes for in-utero surgery. A fetoscope is like a small telescope that can see inside of the uterus (womb) during minimally invasive surgery. The curved scope is used for patients with an anterior placenta (front of uterus), while the straight scope is used for patients with a posterior placenta (back of uterus). The scopes will be used to assist in procedures involving fetoscopic laser photocoagulation (FLP), which is a minimally invasive surgery that uses a small camera (fetoscope) to locate abnormal blood vessel connections in the placenta and seal them off using laser energy. These fetoscopes will be utilized in the diagnosis and management of various fetal conditions that can arise during pregnancy. Outcome data will be reported in a descriptive statistical analysis. The investigators will assess the surgical outcomes, short and long-term morbidity, complications, and gestational age of participants in order to evaluate the benefit of using these devices.
Read the detailed description
The objective of this study is to evaluate the benefit of Karl Storz curved (11508AAK) and straight (11506AAK) fetoscopes for in-utero surgery. The investigators will assess the surgical outcomes, short and long-term morbidity, complications, and gestational age of participants who undergo intrauterine procedures with these devices. The scopes will be used to assist in intrauterine procedures across a variety of fetal conditions, such as TTTS (twin-twin transfusion syndrome), TAPS (twin anemia polycythemia sequence), sFGR (selective fetal growth restriction) or TRAP sequence (twin reversed arterial perfusion). Fetoscopic laser photocoagulation (FLP) can also be used during in-utero surgery to correct abnormal vessels in cases like chorioangioma or vasa previa. Other complex congenital anomalies may require fetal intervention or diagnostic fetoscopy using Storz scopes.
Improvements in the technique, experience and equipment have been associated with better maternal, fetal, and neonatal outcomes in fetal surgery. Smaller fetoscopes are associated with lower rates of premature delivery following FLP. New fetoscopes (11508AAK and 11506AAK) have the potential to improve visualization and the photocoagulation angle. Compared to alternative scopes, these Storz scopes provide a wider angle of view and are longer, enabling better reach to distant areas at the edge of the placenta, especially in cases of higher BMI, higher gestational age, and significant polyhydramnios.
This study is an un-blinded, non-randomized, single arm, feasibility study on a convenience cohort to demonstrate the role of a curved fetoscope device (11508AAK) or straight fetoscope device (11506AAK) among in-utero surgeries. Patients will be enrolled in a consecutive manner and all qualifying, patients who agreed to the use of the curved or straight fetoscopes will be enrolled in the study. Outcome data will be reported as a descriptive statistical analysis. The curved fetoscope (11508AAK) device will be used in monochorionic pregnancies with an anterior placenta requiring in-utero surgery, while the straight fetoscope (11506AAK) will be used in monochorionic pregnancies with a posterior placenta. This device is classified as a significant risk device because it is of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject.
- Conditions
- Fetal Conditions, Maternal; Procedure, Pregnancy Related, Twin to Twin Transfusion Syndrome, In Utero Procedure Affecting Fetus or Newborn, Chorion; Abnormal
- Being tested
- Karl Storz Curved Scope, Karl Storz Straight Scope
- Keywords
- Fetoscope, Fetoscopic Laser Ablation, Diagnostic Fetoscopy
- Medical subject headings
- Fetofetal Transfusion, Antisocial Personality Disorder, Hemangioma, Vasa Previa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Karl Storz Curved ScopeDevice
The curved fetoscope (11508AAK) will be used to view target areas during in-utero procedures for patients with a placenta that sits at the front of the uterus. There are various fetal conditions that may require use of a fetoscope during minimally invasive surgery. These include the need to seal vessels in order to stop blood flow going in a specific direction during pregnancy, abnormal vessels that may need to be sealed, or to break down scar tissue, extra tissue attachments, or blockages.
Karl Storz Straight ScopeDevice
The straight fetoscope (11506AAK) will be used to view target areas during in-utero procedures for patients with a placenta that sits at the back of the uterus. There are various fetal conditions that may require use of a fetoscope during minimally invasive surgery. These include the need to seal vessels in order to stop blood flow going in a specific direction during pregnancy, abnormal vessels that may need to be sealed, or to break down scar tissue, extra tissue attachments, or blockages.
| Study group | Role | What they receive |
|---|---|---|
| Karl Storz Curved or Straight Scope | Experimental | A Karl Storz Curved (11508AAK) or Straight (11506AAK) Fetoscope will be used to provide visualization during in-utero (in the womb) diagnostic and interventional procedures. The curved scope will be used in patients with a placenta that sits at the front of their uterus. The straight scope will be used in patients with a placenta that sits at the back of their uterus. Receives: Device: Karl Storz Curved Scope; Device: Karl Storz Straight Scope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of completed fetoscopic procedures
The rate of successfully completed intrauterine procedures (out of 50 total) using the Karl Storz Curved (11508AAK) or Straight (11506AAk) Fetoscope will be measured.
Measured: 3 years from study start date
Fetal survival at birth
The number of fetuses who undergo an intrauterine fetoscopic procedure using these devices and survive at birth will be analyzed.
Measured: When the last (50th) study participant reaches birth. Likely to be a bit more than 3 years from study start date.
Secondary outcomes (18)
Successful visualization of all targeted vessels
The rate of procedures with these fetoscopes in which there is successful visualization of the targeted vessels will be studied. This measure will be at the discretion of the performing surgeon.
Measured: 3 years from study start date
Successful coagulation of all targeted vessels
The rate of procedures with these fetoscopes in which there is successful coagulation of the targeted vessels will be studied. This measure will be at the discretion of the performing surgeon.
Measured: 3 years from study start date
The rate of preterm labor
The rate of preterm labor following a procedure using these fetoscopes will be analyzed.
Measured: When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.
The rate of preterm premature rupture of membranes (PPROM)
The rate of PPROM following a procedure using these fetoscopes will be analyzed.
Measured: When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.
The rate of placental abruption
The rate of placental abruption following a procedure using these fetoscopes will be analyzed.
Measured: When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.
The rate of choriamniotic separation (CAS)
The rate of CAS following a procedure using these fetoscopes will be analyzed.
Measured: When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.
The rate of iatrogenic septostomy
The rate of iatrogenic septostomy following a procedure using these fetoscopes will be analyzed.
Measured: When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.
The rate of completed Solomonizations
The rate of completed Solomonizations (if clinically elected to be performed) during a procedure using these fetoscopes will be analyzed.
Measured: 3 years from study start date
The rate of any perioperative complications (within 24 hours post-procedure)
The rate of any perioperative complications following a procedure using these fetoscopes will be analyzed.
Measured: 24 hours after the last (50th) procedure using these fetoscopes. This will be a bit more than 3 years from study start date.
Fetal survival 48 hours post-procedure
The rate of fetal survival at 48 hours following a procedure using these fetoscopes will be analyzed.
Measured: 24 hours after the last (50th) procedure using these fetoscopes. This will be a bit more than 3 years from study start date.
Rate of TAPS
In cases of twin-to-twin transfusion syndrome (TTTS) and selective fetal growth restriction (sFGR), the rate in which twin-anemia-polycythemia (TAPS) was observed following a procedure using these fetoscopes.
Measured: When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.
Recurrence of TTTS
In cases of twin-to-twin transfusion syndrome (TTTS), the rate in which TTTS recurred following a procedure using these fetoscopes.
Measured: When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.
Neonatal survival 30 days after birth
The rate of neonatal survival at 30 days of life following a procedure using these fetoscopes will be analyzed.
Measured: When the last (50th) study participant reaches 30 days post-birth. This is likely to be a bit longer than 3 years from study start date.
Short term need for ECMO
The rate of ECMO initiation during the first 30 days of life following a procedure using these fetoscopes will be analyzed.
Measured: When the last (50th) study participant reaches 30 days post-birth. This is likely to be a bit longer than 3 years from study start date.
Short term morbidity
The rate of short term morbidity during the first 30 days of life following a procedure using these fetoscopes will be analyzed. Short-term morbidity includes neurological problems, gastrointestinal problems, respiratory problems, infections, and other problems associated with prematurity including but not limited to: necrotizing enterocolitis, bronchopulmonary dysplasia, respiratory distress syndrome, neonatal sepsis, and neonatal intensive care unit admission.
Measured: When the last (50th) study participant reaches 30 days post-birth. This is likely to be a bit longer than 3 years from study start date.
Gestational age at delivery
Gestational age at delivery will be analyzed for study participants who undergo a procedure using these fetoscopes.
Measured: When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.
Time from procedure to delivery
Number of days from procedure to delivery will be analyzed for study participants who undergo a procedure using these fetoscopes.
Measured: When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.
Length of procedure
The length of time (in minutes) of the procedures using these fetoscopes will be analyzed.
Measured: 3 years from study start date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start15 Aug 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Fetal ConditionsStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eyal Krispin, Boston Children's Hospital
- Investigators
- Eyal Krispin, MD, Principal investigator, Fetal Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06056635
- Sponsor's protocol ID
- IRB-P00044063
- Status last verified
- Sep 2024
- First submitted
- 21 Sep 2023
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Petersen SG, Gibbons KS, Luks FI, Lewi L, Diemert A, Hecher K, Dickinson JE, Stirnemann JJ, Ville Y, Devlieger R, Gardener G, Deprest JA. The Impact of Entry Technique and Access Diameter on Prelabour Rupture of Membranes Following Primary Fetoscopic Laser Treatment for Twin-Twin Transfusion Syndrome. Fetal Diagn Ther. 2016;40(2):100-9. doi: 10.1159/000441915. Epub 2016 Apr 14.
PubMed 27073886Papanna R, Block-Abraham D, Mann LK, Buhimschi IA, Bebbington M, Garcia E, Kahlek N, Harman C, Johnson A, Baschat A, Moise KJ Jr. Risk factors associated with preterm delivery after fetoscopic laser ablation for twin-twin transfusion syndrome. Ultrasound Obstet Gynecol. 2014 Jan;43(1):48-53. doi: 10.1002/uog.13206.
PubMed 24013922Diehl W, Diemert A, Grasso D, Sehner S, Wegscheider K, Hecher K. Fetoscopic laser coagulation in 1020 pregnancies with twin-twin transfusion syndrome demonstrates improvement in double-twin survival rate. Ultrasound Obstet Gynecol. 2017 Dec;50(6):728-735. doi: 10.1002/uog.17520.
PubMed 28477345Senat MV, Deprest J, Boulvain M, Paupe A, Winer N, Ville Y. Endoscopic laser surgery versus serial amnioreduction for severe twin-to-twin transfusion syndrome. N Engl J Med. 2004 Jul 8;351(2):136-44. doi: 10.1056/NEJMoa032597. Epub 2004 Jul 6.
PubMed 15238624Deprest JA, Van Schoubroeck D, Van Ballaer PP, Flageole H, Van Assche FA, Vandenberghe K. Alternative technique for Nd: YAG laser coagulation in twin-to-twin transfusion syndrome with anterior placenta. Ultrasound Obstet Gynecol. 1998 May;11(5):347-52. doi: 10.1046/j.1469-0705.1998.11050347.x.
PubMed 9644775Middeldorp JM, Lopriore E, Sueters M, Klumper FJ, Kanhai HH, Vandenbussche FP, Oepkes D. Twin-to-twin transfusion syndrome after 26 weeks of gestation: is there a role for fetoscopic laser surgery? BJOG. 2007 Jun;114(6):694-8. doi: 10.1111/j.1471-0528.2007.01337.x.
PubMed 17516960Shamshirsaz AA, Javadian P, Ruano R, Haeri S, Sangi-Haghpeykar H, Lee TC, Molohon J, Cass DL, Salmanian B, Mollett L, Moaddab A, Espinosa J, Olutoye OO, Belfort MA. Comparison between laparoscopically assisted and standard fetoscopic laser ablation in patients with anterior and posterior placentation in twin-twin transfusion syndrome: a single center study. Prenat Diagn. 2015 Apr;35(4):376-81. doi: 10.1002/pd.4552. Epub 2015 Mar 1.
PubMed 25559783Krispin E, Nassr AA, Espinoza J, Donepudi R, Sun RC, Sanz-Cortes M, Mostafaei S, Belfort MA, Shamshirsaz AA. Outcomes of laparoscopy-assisted fetoscopic laser photocoagulation for twin-twin transfusion syndrome: An established alternative for inaccessible anterior placenta. Prenat Diagn. 2021 Nov;41(12):1582-1588. doi: 10.1002/pd.5955. Epub 2021 Oct 17.
PubMed 34658043Jarboe MD, Berman DR, Wright T, Treadwell MC, Mychaliska GB. Novel Application of Laparoscopic Ultrasound for Fetoscopic Laser Ablation in Twin-Twin Transfusion Syndrome with Complete Anterior Placenta. Fetal Diagn Ther. 2017;41(1):71-75. doi: 10.1159/000439526. Epub 2015 Nov 11.
PubMed 26555815Quintero RA, Chmait RH, Bornick PW, Kontopoulos EV. Trocar-assisted selective laser photocoagulation of communicating vessels: a technique for the laser treatment of patients with twin-twin transfusion syndrome with inaccessible anterior placentas. J Matern Fetal Neonatal Med. 2010 Apr;23(4):330-4. doi: 10.3109/14767050903177177.
PubMed 19941443Quintero RA, Bornick PW, Allen MH, Johson PK. Selective laser photocoagulation of communicating vessels in severe twin-twin transfusion syndrome in women with an anterior placenta. Obstet Gynecol. 2001 Mar;97(3):477-81. doi: 10.1016/s0029-7844(00)01172-8.
PubMed 11256383Huber A, Baschat AA, Bregenzer T, Diemert A, Tchirikov M, Hackeloer BJ, Hecher K. Laser coagulation of placental anastomoses with a 30 degrees fetoscope in severe mid-trimester twin-twin transfusion syndrome with anterior placenta. Ultrasound Obstet Gynecol. 2008 Apr;31(4):412-6. doi: 10.1002/uog.5283.
PubMed 18330890Van Der Veeken L, Couck I, Van Der Merwe J, De Catte L, Devlieger R, Deprest J, Lewi L. Laser for twin-to-twin transfusion syndrome: a guide for endoscopic surgeons. Facts Views Vis Obgyn. 2019 Sep;11(3):197-205.
PubMed 32082525Tollenaar LSA, Slaghekke F, Lewi L, Colmant C, Lanna M, Weingertner AS, Ryan G, Arevalo S, Klaritsch P, Tavares de Sousa M, Khalil A, Papanna R, Gardener GJ, Bevilacqua E, Kostyukov KV, Bahtiyar MO, Kilby MD, Tiblad E, Oepkes D, Lopriore E. Spontaneous twin anemia polycythemia sequence: diagnosis, management, and outcome in an international cohort of 249 cases. Am J Obstet Gynecol. 2021 Feb;224(2):213.e1-213.e11. doi: 10.1016/j.ajog.2020.07.041. Epub 2020 Jul 27.
PubMed 32730900Tollenaar LSA, Lopriore E, Faiola S, Lanna M, Stirnemann J, Ville Y, Lewi L, Devlieger R, Weingertner AS, Favre R, Hobson SR, Ryan G, Rodo C, Arevalo S, Klaritsch P, Greimel P, Hecher K, de Sousa MT, Khalil A, Thilaganathan B, Bergh EP, Papanna R, Gardener GJ, Carlin A, Bevilacqua E, Sakalo VA, Kostyukov KV, Bahtiyar MO, Wilpers A, Kilby MD, Tiblad E, Oepkes D, Middeldorp JM, Haak MC, Klumper FJCM, Akkermans J, Slaghekke F. Post-Laser Twin Anemia Polycythemia Sequence: Diagnosis, Management, and Outcome in an International Cohort of 164 Cases. J Clin Med. 2020 Jun 5;9(6):1759. doi: 10.3390/jcm9061759.
PubMed 32517071
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on the Role of Karl Storz Curved and Straight Fetoscopes (11508AAK and 11506AAK) for Fetoscopic Intrauterine Procedures
- ClinicalTrials.gov ID
- NCT06056635
- Acronym / sponsor ID
- IRB-P00044063
- Conditions
- Fetal Conditions, Maternal; Procedure, Pregnancy Related, Twin to Twin Transfusion Syndrome, In Utero Procedure Affecting Fetus or Newborn, Chorion; Abnormal
- Keywords
- Fetoscope, Fetoscopic Laser Ablation, Diagnostic Fetoscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this research study, the investigators want to learn more about the role of new innovative surgical devices, the Karl Storz Curved and Straight Fetoscopes for in-utero surgery. A fetoscope is like a small telescope that can see inside of the uterus (womb) during minimally invasive surgery. The curved scope is used for patients with an anterior placenta (front of uterus), while the straight scope is used for patients with a posterior placenta (back of uterus). The scopes will be used to assist in procedures involving fetoscopic laser photocoagulation (FLP), which is a minimally invasive surgery that uses a small camera (fetoscope) to locate abnormal blood vessel connections in the placenta and seal them off using laser energy. These fetoscopes will be utilized in the diagnosis and management of various fetal conditions that can arise during pregnancy. Outcome data will be reported in a descriptive statistical analysis. The investigators will assess the surgical outcomes, short and long-term morbidity, complications, and gestational age of participants in order to evaluate the benefit of using these devices.
Detailed description
The objective of this study is to evaluate the benefit of Karl Storz curved (11508AAK) and straight (11506AAK) fetoscopes for in-utero surgery. The investigators will assess the surgical outcomes, short and long-term morbidity, complications, and gestational age of participants who undergo intrauterine procedures with these devices. The scopes will be used to assist in intrauterine procedures across a variety of fetal conditions, such as TTTS (twin-twin transfusion syndrome), TAPS (twin anemia polycythemia sequence), sFGR (selective fetal growth restriction) or TRAP sequence (twin reversed arterial perfusion). Fetoscopic laser photocoagulation (FLP) can also be used during in-utero surgery to correct abnormal vessels in cases like chorioangioma or vasa previa. Other complex congenital anomalies may require fetal intervention or diagnostic fetoscopy using Storz scopes.
Improvements in the technique, experience and equipment have been associated with better maternal, fetal, and neonatal outcomes in fetal surgery. Smaller fetoscopes are associated with lower rates of premature delivery following FLP. New fetoscopes (11508AAK and 11506AAK) have the potential to improve visualization and the photocoagulation angle. Compared to alternative scopes, these Storz scopes provide a wider angle of view and are longer, enabling better reach to distant areas at the edge of the placenta, especially in cases of higher BMI, higher gestational age, and significant polyhydramnios.
This study is an un-blinded, non-randomized, single arm, feasibility study on a convenience cohort to demonstrate the role of a curved fetoscope device (11508AAK) or straight fetoscope device (11506AAK) among in-utero surgeries. Patients will be enrolled in a consecutive manner and all qualifying, patients who agreed to the use of the curved or straight fetoscopes will be enrolled in the study. Outcome data will be reported as a descriptive statistical analysis. The curved fetoscope (11508AAK) device will be used in monochorionic pregnancies with an anterior placenta requiring in-utero surgery, while the straight fetoscope (11506AAK) will be used in monochorionic pregnancies with a posterior placenta. This device is classified as a significant risk device because it is of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Karl Storz Curved or Straight Scope | Experimental | Device: Karl Storz Curved Scope, Device: Karl Storz Straight ScopeA Karl Storz Curved (11508AAK) or Straight (11506AAK) Fetoscope will be used to provide visualization during in-utero (in the womb) diagnostic and interventional procedures. The curved scope will be used in patients with a placenta that sits at the front of their uterus. The straight scope will be used in patients with a placenta that sits at the back of their uterus. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant patient with a condition requiring in-utero surgery
- Patient must be eligible for anesthesia
- Patient and father of the fetus (if available) are able to provide signed informed consent
Key exclusion criteria (7 listed)
- Allergy or previous adverse reaction to any ancillary medication specified in this protocol that has no alternative
- Preterm labor, preeclampsia, or uterine anomaly (e.g., large fibroid tumor) in the index pregnancy
- Suspicion of major recognized congenital syndrome on ultrasound or MRI that is not compatible with postnatal life
- Pre-pregnancy maternal BMI greater than 40
- High risk for fetal hemophilia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Karl Storz Curved ScopeThe curved fetoscope (11508AAK) will be used to view target areas during in-utero procedures for patients with a placenta that sits at the front of the uterus. There are various fetal conditions that may require use of a fetoscope during minimally invasive surgery. These include the need to seal vessels in order to stop blood flow going in a specific direction during pregnancy, abnormal vessels that may need to be sealed, or to break down scar tissue, extra tissue attachments, or blockages. | Device | Karl Storz Curved or Straight Scope |
| Karl Storz Straight ScopeThe straight fetoscope (11506AAK) will be used to view target areas during in-utero procedures for patients with a placenta that sits at the back of the uterus. There are various fetal conditions that may require use of a fetoscope during minimally invasive surgery. These include the need to seal vessels in order to stop blood flow going in a specific direction during pregnancy, abnormal vessels that may need to be sealed, or to break down scar tissue, extra tissue attachments, or blockages. | Device | Karl Storz Curved or Straight Scope |
Primary outcome
Rate of completed fetoscopic procedures
Time frame: 3 years from study start date
The rate of successfully completed intrauterine procedures (out of 50 total) using the Karl Storz Curved (11508AAK) or Straight (11506AAk) Fetoscope will be measured.
Fetal survival at birth
Time frame: When the last (50th) study participant reaches birth. Likely to be a bit more than 3 years from study start date.
The number of fetuses who undergo an intrauterine fetoscopic procedure using these devices and survive at birth will be analyzed.
18 secondary outcomes
Successful visualization of all targeted vessels
Time frame: 3 years from study start date
Successful coagulation of all targeted vessels
Time frame: 3 years from study start date
The rate of preterm labor
Time frame: When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.
The rate of preterm premature rupture of membranes (PPROM)
Time frame: When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.
The rate of placental abruption
Time frame: When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.
The rate of choriamniotic separation (CAS)
Time frame: When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.
The rate of iatrogenic septostomy
Time frame: When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.
The rate of completed Solomonizations
Time frame: 3 years from study start date
The rate of any perioperative complications (within 24 hours post-procedure)
Time frame: 24 hours after the last (50th) procedure using these fetoscopes. This will be a bit more than 3 years from study start date.
Fetal survival 48 hours post-procedure
Time frame: 24 hours after the last (50th) procedure using these fetoscopes. This will be a bit more than 3 years from study start date.
Rate of TAPS
Time frame: When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.
Recurrence of TTTS
Time frame: When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.
Neonatal survival 30 days after birth
Time frame: When the last (50th) study participant reaches 30 days post-birth. This is likely to be a bit longer than 3 years from study start date.
Short term need for ECMO
Time frame: When the last (50th) study participant reaches 30 days post-birth. This is likely to be a bit longer than 3 years from study start date.
Short term morbidity
Time frame: When the last (50th) study participant reaches 30 days post-birth. This is likely to be a bit longer than 3 years from study start date.
Gestational age at delivery
Time frame: When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.
Time from procedure to delivery
Time frame: When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.
Length of procedure
Time frame: 3 years from study start date
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Background: PubMed 27073886Petersen SG, Gibbons KS, Luks FI, Lewi L, Diemert A, Hecher K, Dickinson JE, Stirnemann JJ, Ville Y, Devlieger R, Gardener G, Deprest JA. The Impact of Entry Technique and Access Diameter on Prelabour Rupture of Membranes Following Primary Fetoscopic Laser Treatment for Twin-Twin Transfusion Syndrome. Fetal Diagn Ther. 2016;40(2):100-9. doi: 10.1159/000441915. Epub 2016 Apr 14.
- Background: PubMed 24013922Papanna R, Block-Abraham D, Mann LK, Buhimschi IA, Bebbington M, Garcia E, Kahlek N, Harman C, Johnson A, Baschat A, Moise KJ Jr. Risk factors associated with preterm delivery after fetoscopic laser ablation for twin-twin transfusion syndrome. Ultrasound Obstet Gynecol. 2014 Jan;43(1):48-53. doi: 10.1002/uog.13206.
- Background: PubMed 28477345Diehl W, Diemert A, Grasso D, Sehner S, Wegscheider K, Hecher K. Fetoscopic laser coagulation in 1020 pregnancies with twin-twin transfusion syndrome demonstrates improvement in double-twin survival rate. Ultrasound Obstet Gynecol. 2017 Dec;50(6):728-735. doi: 10.1002/uog.17520.
- Background: PubMed 15238624Senat MV, Deprest J, Boulvain M, Paupe A, Winer N, Ville Y. Endoscopic laser surgery versus serial amnioreduction for severe twin-to-twin transfusion syndrome. N Engl J Med. 2004 Jul 8;351(2):136-44. doi: 10.1056/NEJMoa032597. Epub 2004 Jul 6.
- Background: PubMed 9644775Deprest JA, Van Schoubroeck D, Van Ballaer PP, Flageole H, Van Assche FA, Vandenberghe K. Alternative technique for Nd: YAG laser coagulation in twin-to-twin transfusion syndrome with anterior placenta. Ultrasound Obstet Gynecol. 1998 May;11(5):347-52. doi: 10.1046/j.1469-0705.1998.11050347.x.
- Background: PubMed 17516960Middeldorp JM, Lopriore E, Sueters M, Klumper FJ, Kanhai HH, Vandenbussche FP, Oepkes D. Twin-to-twin transfusion syndrome after 26 weeks of gestation: is there a role for fetoscopic laser surgery? BJOG. 2007 Jun;114(6):694-8. doi: 10.1111/j.1471-0528.2007.01337.x.
- Background: PubMed 25559783Shamshirsaz AA, Javadian P, Ruano R, Haeri S, Sangi-Haghpeykar H, Lee TC, Molohon J, Cass DL, Salmanian B, Mollett L, Moaddab A, Espinosa J, Olutoye OO, Belfort MA. Comparison between laparoscopically assisted and standard fetoscopic laser ablation in patients with anterior and posterior placentation in twin-twin transfusion syndrome: a single center study. Prenat Diagn. 2015 Apr;35(4):376-81. doi: 10.1002/pd.4552. Epub 2015 Mar 1.
- Background: PubMed 34658043Krispin E, Nassr AA, Espinoza J, Donepudi R, Sun RC, Sanz-Cortes M, Mostafaei S, Belfort MA, Shamshirsaz AA. Outcomes of laparoscopy-assisted fetoscopic laser photocoagulation for twin-twin transfusion syndrome: An established alternative for inaccessible anterior placenta. Prenat Diagn. 2021 Nov;41(12):1582-1588. doi: 10.1002/pd.5955. Epub 2021 Oct 17.
- Background: PubMed 26555815Jarboe MD, Berman DR, Wright T, Treadwell MC, Mychaliska GB. Novel Application of Laparoscopic Ultrasound for Fetoscopic Laser Ablation in Twin-Twin Transfusion Syndrome with Complete Anterior Placenta. Fetal Diagn Ther. 2017;41(1):71-75. doi: 10.1159/000439526. Epub 2015 Nov 11.
- Background: PubMed 19941443Quintero RA, Chmait RH, Bornick PW, Kontopoulos EV. Trocar-assisted selective laser photocoagulation of communicating vessels: a technique for the laser treatment of patients with twin-twin transfusion syndrome with inaccessible anterior placentas. J Matern Fetal Neonatal Med. 2010 Apr;23(4):330-4. doi: 10.3109/14767050903177177.
- Background: PubMed 11256383Quintero RA, Bornick PW, Allen MH, Johson PK. Selective laser photocoagulation of communicating vessels in severe twin-twin transfusion syndrome in women with an anterior placenta. Obstet Gynecol. 2001 Mar;97(3):477-81. doi: 10.1016/s0029-7844(00)01172-8.
- Background: PubMed 18330890Huber A, Baschat AA, Bregenzer T, Diemert A, Tchirikov M, Hackeloer BJ, Hecher K. Laser coagulation of placental anastomoses with a 30 degrees fetoscope in severe mid-trimester twin-twin transfusion syndrome with anterior placenta. Ultrasound Obstet Gynecol. 2008 Apr;31(4):412-6. doi: 10.1002/uog.5283.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eyal Krispin, MD principal investigator
Fetal Surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Karl Storz Curved Scope and Karl Storz Straight Scope in people with Fetal Conditions and Maternal; Procedure, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brittany Gudanowski (617-919-6658, Brittany.Gudanowski@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of completed fetoscopic procedures (time frame: 3 years from study start date). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06056635, which also lists 31 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.