Twin Monochorionic Diamniotic PlacentaNCT06022510
Safety and Efficacy of Fetoscopes Used in Fetoscopic Selective Laser Photocoagulation
A study testing Fetoscopy Sets for Anterior and Posterior Placentas in people with Twin Monochorionic Diamniotic Placenta, run by Michael A Belfort at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of the investigational fetoscopes used in patients undergoing fetoscopic selective laser photocoagulation for complicated monochorionic-diamniotic pregnancies. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Twin Monochorionic Diamniotic Placenta
- What is being tested?
- Fetoscopy Sets for Anterior and Posterior Placentas
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2025to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients who are eligible and elect to undergo fetoscopic selective laser photocoagulation for the treatment of complicated monochorionic-diamniotic pregnancies.
Who cannot join
- Patients who do not elect to undergo fetoscopic laser photocoagulation for treatment of complicated monochorionic-diamniotic pregnancies.
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Children's Hospital - Pavilion for Women
Houston, Texas, 77030
About this study
Official title: Safety and Efficacy of Fetoscopes Used in Fetoscopic Selective Laser Photocoagulation for Complicated Monochorionic-Diamniotic Pregnancies
The purpose of this study is to evaluate the safety and efficacy of the investigational fetoscopes used in patients undergoing fetoscopic selective laser photocoagulation for complicated monochorionic-diamniotic pregnancies.
Read the detailed description
All patients who choose to undergo fetoscopic selective laser photocoagulation (S-PLC) at Texas Children's Fetal Center will be offered participation in this research study by study investigators. Description of study rationale and design and a focused interview by the study coordinator to afford potential participants a formal opportunity to examine what they have learned about the research study in the course of their evaluation and discuss how they feel about enrolling in the research study. Once the patient is deemed eligible the informed consent process will be reviewed. If patients elect to participate in the study, informed consent will be obtained, and patients provided a copy of the signed consent.
Fetoscopic Procedure: Selective laser photocoagulation (S-PLC) is standard of care for the treatment of complicated monochorionic twin pregnancies and will be performed with the same technique in this study as it is with the use of the currently approved fetoscopes. In the majority of cases, in utero access has been achieved using a small percutaneous incision under ultrasound guidance with the instruments inserted through the maternal abdomen, uterine wall and into the recipient fetus' gestational sac. The fetoscope is then used to "map" the placental vascular pattern. Communicating vessels between the fetuses are ablated using laser energy via a 400-600 micron laser fiber that has been introduced through the instrument channel of the operating sheath. Intravenous sedation with local anesthesia at the site of insertion has been found to provide sufficient maternal anesthesia for the procedure. At the completion of the S-PLC, the excess amniotic fluid in the recipient twin's sac is removed to achieve a normal volume.
Follow-Up: The investigators will follow patients for the immediate post-procedure period (until they leave the OR).
- Conditions
- Twin Monochorionic Diamniotic Placenta
- Being tested
- Fetoscopy Sets for Anterior and Posterior Placentas
- Keywords
- twin-twin transfusion syndrome, TTTS, twin anemia polycythemia sequence, TAPS, selective intrauterine growth restriction, sIUGR
- Medical subject headings
- Fetofetal Transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetoscopy Sets for Anterior and Posterior PlacentasDevice
Also called Karl Storz Miniature Straight Forward Telescope 0 Degrees Set - Straight or 11506 AAK, Karl Storz Miniature Straight Forward Telescope 0 Degrees Set - Curved or 11508 AAK
Patients who choose to undergo fetoscopic surgery for a complicated monochorionic-diamniotic pregnancy will be offered participation in this study. All patients will undergo selective laser photocoagulation with the use of the fetoscopes in this study.
| Study group | Role | What they receive |
|---|---|---|
| Fetoscopes for Selective Laser Photocoagulation | Experimental | Single arm study. All patients will undergo selective laser photocoagulation with the use of the fetoscopes in this study. Receives: Device: Fetoscopy Sets for Anterior and Posterior Placentas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events
Number of adverse events associated with the investigational device.
Measured: Immediate Post-Procedure Period (from surgery start until surgery finish)
Number of device defects, malfunctions, or failures
Number of device defects, malfunctions, or failures and whether the device performed as intended.
Measured: Immediate Post-Procedure Period (from surgery start until surgery finish)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study startApr 2025 (estimated)
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Why it stopped: These fetoscopes have obtained FDA approval under Karl Storz's existing HDE (H040005) for their fetoscopy instrument set. No participants were enrolled as we did not receive the fetoscopes until early 2025 and the IDE is closed as of April 2025.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Twin Monochorionic Diamniotic PlacentaStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael A Belfort
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor College of Medicine
- Responsible party
- Sponsor-investigator, Michael A Belfort, Baylor College of Medicine
- Investigators
- Michael A Belfort, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06022510
- Sponsor's protocol ID
- H-53644
- Status last verified
- Apr 2026
- First submitted
- 22 Aug 2023
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Fetoscopes Used in Fetoscopic Selective Laser Photocoagulation for Complicated Monochorionic-Diamniotic Pregnancies
- ClinicalTrials.gov ID
- NCT06022510
- Acronym / sponsor ID
- H-53644
- Conditions
- Twin Monochorionic Diamniotic Placenta
- Keywords
- twin-twin transfusion syndrome, TTTS, twin anemia polycythemia sequence, TAPS, selective intrauterine growth restriction, sIUGR
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: These fetoscopes have obtained FDA approval under Karl Storz's existing HDE (H040005) for their fetoscopy instrument set. No participants were enrolled as we did not receive the fetoscopes until early 2025 and the IDE is closed as of April 2025.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Michael A BelfortUniversity, hospital or other
- Collaborators
- Baylor College of Medicine
- Study start
- Apr 2025 (estimated)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 5 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.
The purpose of this study is to evaluate the safety and efficacy of the investigational fetoscopes used in patients undergoing fetoscopic selective laser photocoagulation for complicated monochorionic-diamniotic pregnancies.
Detailed description
All patients who choose to undergo fetoscopic selective laser photocoagulation (S-PLC) at Texas Children's Fetal Center will be offered participation in this research study by study investigators. Description of study rationale and design and a focused interview by the study coordinator to afford potential participants a formal opportunity to examine what they have learned about the research study in the course of their evaluation and discuss how they feel about enrolling in the research study. Once the patient is deemed eligible the informed consent process will be reviewed. If patients elect to participate in the study, informed consent will be obtained, and patients provided a copy of the signed consent.
Fetoscopic Procedure: Selective laser photocoagulation (S-PLC) is standard of care for the treatment of complicated monochorionic twin pregnancies and will be performed with the same technique in this study as it is with the use of the currently approved fetoscopes. In the majority of cases, in utero access has been achieved using a small percutaneous incision under ultrasound guidance with the instruments inserted through the maternal abdomen, uterine wall and into the recipient fetus' gestational sac. The fetoscope is then used to "map" the placental vascular pattern. Communicating vessels between the fetuses are ablated using laser energy via a 400-600 micron laser fiber that has been introduced through the instrument channel of the operating sheath. Intravenous sedation with local anesthesia at the site of insertion has been found to provide sufficient maternal anesthesia for the procedure. At the completion of the S-PLC, the excess amniotic fluid in the recipient twin's sac is removed to achieve a normal volume.
Follow-Up: The investigators will follow patients for the immediate post-procedure period (until they leave the OR).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fetoscopes for Selective Laser Photocoagulation | Experimental | Device: Fetoscopy Sets for Anterior and Posterior PlacentasSingle arm study. All patients will undergo selective laser photocoagulation with the use of the fetoscopes in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are eligible and elect to undergo fetoscopic selective laser photocoagulation for the treatment of complicated monochorionic-diamniotic pregnancies.
Key exclusion criteria (1 listed)
- Patients who do not elect to undergo fetoscopic laser photocoagulation for treatment of complicated monochorionic-diamniotic pregnancies.
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 |
|---|---|---|
| Fetoscopy Sets for Anterior and Posterior PlacentasAlso: Karl Storz Miniature Straight Forward Telescope 0 Degrees Set - Straight or 11506 AAK, Karl Storz Miniature Straight Forward Telescope 0 Degrees Set - Curved or 11508 AAKPatients who choose to undergo fetoscopic surgery for a complicated monochorionic-diamniotic pregnancy will be offered participation in this study. All patients will undergo selective laser photocoagulation with the use of the fetoscopes in this study. | Device | Fetoscopes for Selective Laser Photocoagulation |
Primary outcome
Number of adverse events
Time frame: Immediate Post-Procedure Period (from surgery start until surgery finish)
Number of adverse events associated with the investigational device.
Number of device defects, malfunctions, or failures
Time frame: Immediate Post-Procedure Period (from surgery start until surgery finish)
Number of device defects, malfunctions, or failures and whether the device performed as intended.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
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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. This study is not recruiting at the moment.
Michael A Belfort, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fetoscopy Sets for Anterior and Posterior Placentas in people with Twin Monochorionic Diamniotic Placenta, run by Michael A Belfort 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 29 Apr 2026. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events (time frame: Immediate Post-Procedure Period (from surgery start until surgery finish)). 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?
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 29 Apr 2026.