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 range18 Years

SexFEMALE

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.

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