Neural Tube DefectsNCT03856034
Laparotomy Versus Percutaneous Endoscopic Correction of Myelomeningocele
A study testing Fetoscopy in people with Neural Tube Defects and Spina Bifida, run by USFetus at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the feasibility of a fetoscopic surgical technique for antenatal correction of fetal myelomeningocele. Two surgical approaches will be utilized. The percutaneous approach will be offered to participants with a posterior placenta. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Neural Tube Defects, Spina Bifida, Myelomeningocele
- What is being tested?
- Fetoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Nov 2018to 31 Dec 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Myelomeningocele (including myeloschisis) at level T1 through S1 with hindbrain herniation. Lesion level and hindbrain herniation will be confirmed by MRI and ultrasonography.
- Maternal age ≥18 years.
- Gestational age of 19 to 27 6/7 weeks' gestation as determined by clinical information and evaluation of first ultrasound.
- Balanced karyotype with written confirmation of culture results. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is at 24 weeks or more.
- Positive evaluation of social work consult indicating the patient is capable of consenting to the procedure and has the appropriate social support system to participate in the study.
- Positive evaluation from pediatric neurology consult.
- Willing to remain in the greater Wellington or Pasadena area (within a 30-minute car ride) for remainder of the pregnancy and deliver at Wellington Regional Medical Center or Huntington Memorial Hospital for postnatal management. The participants must be willing to return to our center for the 12, 24, 30, 48, and 60 months for follow-up evaluation.
Who cannot join
- Multiple gestation
- Insulin-dependent pregestational diabetes
- Presence of a fetal anomaly not related to myelomeningocele. A fetal echocardiogram will be conducted before surgery and if the finding is abnormal, the patient will be excluded.
- Fetal kyphosis of 30 degrees or more, assessed by ultrasound or MRI.
- Presence of uterine cervical cerclage or history of incompetent cervix.
- Placenta previa or placental abruption.
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- Short cervix < 25 mm measured by cervical ultrasound.
- Obesity as defined by body mass index (BMI) of 35 or greater.
- History of previous spontaneous singleton delivery prior to 37 weeks.
- Maternal-fetal Rh isoimmunization, Kell sensitization or a history of neonatal alloimmune thrombocytopenia.
- Maternal HIV or Hepatitis-B status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis B status is unknown, the patient must be tested and found to have negative results before she can be enrolled.
- Known Hepatitis-C positivity. If the patient's Hepatitis C status is unknown, she does not need to be screened.
- Uterine anomaly such as large (greater than 6 cm) fibroids, cervical fibroids or multiple fibroids or Mullerian duct abnormality.
- Other maternal medical condition which is a contraindication to surgery or anesthesia.
- Patient does not have a support person (e.g., husband, partner, parents).
- Inability to comply with the travel and follow-up requirements of the study.
- Patient does not meet psychosocial criteria as determined by the social worker evaluation.
- Participation in another intervention study that influences maternal and fetal morbidity and mortality.
- Maternal hypertension as determined by the investigator, which would increase the risk of preeclampsia or preterm delivery (including, but not limited to: uncontrolled hypertension, chronic hypertension with end organ damage and new onset hypertension in current pregnancy).
- Bicornuate uterus or any other uterine malformation the PI decides is not safe for surgery.
- Nickel allergy.
- Maternal request to undergo open fetal surgery for the antenatal correction of open spina bifida at our institution primarily or after failed fetoscopic approach.
- Known maternal hypersensitivity to bovine collagen or chondroitin materials.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Southern California / Huntington Memorial Hospital
Los Angeles, California, 91105
Ramen Chmait, MD, 626-356-3360, chmait@usc.edu
Arlyn Llanes, RN, 626-356-3360, arlyn.llanes@med.usc.edu
- Recruiting
Wellington Regional Medical Center
Wellington, Florida, 33141
Ruben Quintero, MD, 720-753-3825, q@the-fetal-institute.com
Eftichia Kontopoulos, MD, 720-753-3825, k@the-fetal-institute.com
About this study
Official title: In Utero Endoscopic Correction of Myelomeningocele: Laparotomy Versus Percutaneous - A Pilot Study
The purpose of this study is to evaluate the feasibility of a fetoscopic surgical technique for antenatal correction of fetal myelomeningocele. Two surgical approaches will be utilized. The percutaneous approach will be offered to participants with a posterior placenta. The laparotomy/uterine exteriorization approach will be offered to participants regardless of placental location.
- Being tested
- Fetoscopy
- Keywords
- spina bifida, myelomeningocele, neural tube defect, chiari malformation, fetoscopy, percutaneous, fetus
- Medical subject headings
- Neural Tube Defects, Spinal Dysraphism, Meningomyelocele, Arnold-Chiari Malformation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FetoscopyDevice
Patients will receive fetoscopic repair of myelomeningocele. Patients with an anterior placenta will undergo the laparotomy with uterine exteriorization approach. Patients with a posterior placenta will undergo the percutaneous approach (or, if patient prefers, the laparotomy with uterine exteriorization approach).
| Study group | Role | What they receive |
|---|---|---|
| Fetoscopic repair | Experimental | Not described Receives: Device: Fetoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful in-utero fetoscopic myelomeningocele closures using either laparotomy or percutaneous techniques
Successful fetoscopic closure of the spinal defect and reversal of hindbrain herniation as assessed by ultrasound and MRI prior to delivery
Measured: At time of surgery until delivery, up to 21 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start2 Nov 2018
- Primary completion2 Nov 2020 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neural Tube DefectsStudies of the same condition, open and under way.
- 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
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- USFetus
- Sponsor type
- University, hospital or other
- Collaborators
- Wellington Hospital, University of Southern California
- Responsible party
- Sponsor
- Investigators
- Ruben Quintero, MD, Principal investigator, Wellington Regional Medical CenterRamen Chmait, MD, Principal investigator, University of Southern California/ Huntington Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856034
- Sponsor's protocol ID
- 1249628
- Status last verified
- Nov 2019
- First submitted
- 5 Feb 2019
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Utero Endoscopic Correction of Myelomeningocele: Laparotomy Versus Percutaneous - A Pilot Study
- ClinicalTrials.gov ID
- NCT03856034
- Acronym / sponsor ID
- 1249628
- Keywords
- spina bifida, myelomeningocele, neural tube defect, chiari malformation, fetoscopy, percutaneous, fetus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- USFetusUniversity, hospital or other
- Collaborators
- Wellington Hospital, University of Southern California
- Study start
- 2 Nov 2018 (actual)
- Primary completion
- 2 Nov 2020 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Feb 2019 (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.
The purpose of this study is to evaluate the feasibility of a fetoscopic surgical technique for antenatal correction of fetal myelomeningocele. Two surgical approaches will be utilized. The percutaneous approach will be offered to participants with a posterior placenta. The laparotomy/uterine exteriorization approach will be offered to participants regardless of placental location.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fetoscopic repair | Experimental | Device: Fetoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Myelomeningocele (including myeloschisis) at level T1 through S1 with hindbrain herniation. Lesion level and hindbrain herniation will be confirmed by MRI and ultrasonography.
- Maternal age ≥18 years.
- Gestational age of 19 to 27 6/7 weeks' gestation as determined by clinical information and evaluation of first ultrasound.
- Balanced karyotype with written confirmation of culture results. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is at 24 weeks or more.
- Positive evaluation of social work consult indicating the patient is capable of consenting to the procedure and has the appropriate social support system to participate in the study.
Key exclusion criteria (23 listed)
- Multiple gestation
- Insulin-dependent pregestational diabetes
- Presence of a fetal anomaly not related to myelomeningocele. A fetal echocardiogram will be conducted before surgery and if the finding is abnormal, the patient will be excluded.
- Fetal kyphosis of 30 degrees or more, assessed by ultrasound or MRI.
- Presence of uterine cervical cerclage or history of incompetent cervix.
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 |
|---|---|---|
| FetoscopyPatients will receive fetoscopic repair of myelomeningocele. Patients with an anterior placenta will undergo the laparotomy with uterine exteriorization approach. Patients with a posterior placenta will undergo the percutaneous approach (or, if patient prefers, the laparotomy with uterine exteriorization approach). | Device | Fetoscopic repair |
Primary outcome
Rate of successful in-utero fetoscopic myelomeningocele closures using either laparotomy or percutaneous techniques
Time frame: At time of surgery until delivery, up to 21 weeks
Successful fetoscopic closure of the spinal defect and reversal of hindbrain herniation as assessed by ultrasound and MRI prior to delivery
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 13 Nov 2019.
- 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.
Ruben Quintero, MD principal investigator
Wellington Regional Medical Center
Ramen Chmait, MD principal investigator
University of Southern California/ Huntington Memorial Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fetoscopy in people with Neural Tube Defects and Spina Bifida, run by USFetus at 2 sites 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 7 inclusion and 23 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 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Ruben Quintero, MD (720-753-3825, q@the-fetal-institute.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of successful in-utero fetoscopic myelomeningocele closures using either laparotomy or percutaneous techniques (time frame: At time of surgery until delivery, up to 21 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Nov 2019.