WithdrawnNot Applicable

Safety and Efficacy of Fetoscopes Used in Fetoscopic Selective Laser Photocoagulation

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.

United States0Started 2025-04

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients who are eligible and elect to undergo fetoscopic selective laser photocoagulation for the treatment of complicated monochorionic-diamniotic pregnancies. Exclusion Criteria: * Patients who do not elect to undergo fetoscopic laser photocoagulation for treatment of complicated monochorionic-diamniotic pregnancies.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of adverse events

Timeframe: Immediate Post-Procedure Period (from surgery start until surgery finish)

Number of device defects, malfunctions, or failures

Timeframe: Immediate Post-Procedure Period (from surgery start until surgery finish)

Trial details

NCT IDNCT06022510

SponsorMichael A Belfort

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-01

View on ClinicalTrials.gov More Twin Monochorionic Diamniotic Placenta trials