Safety and Efficacy of Fetoscopes Used in Fetoscopic Selective Laser Photocoagulation

NCT06022510 | Withdrawn DMC FDA Device

• 1 other identifier: H-53644
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Twin Monochorionic Diamniotic Placenta

Keywords

twin-twin transfusion syndrome; TTTS; twin anemia polycythemia sequence; TAPS; selective intrauterine growth restriction; sIUGR

Outcome Measures

Primary Outcomes (2)

• Number of adverse events

  Number of adverse events associated with the investigational device.

  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.

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

Study Arms (1)

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.

Device: Fetoscopy Sets for Anterior and Posterior Placentas

Interventions

Fetoscopy Sets for Anterior and Posterior Placentas DEVICE

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.

Also known as: 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

Fetoscopes for Selective Laser Photocoagulation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are eligible and elect to undergo fetoscopic selective laser photocoagulation for the treatment of complicated monochorionic-diamniotic pregnancies.

You may not qualify if:

• Patients who do not elect to undergo fetoscopic laser photocoagulation for treatment of complicated monochorionic-diamniotic pregnancies.

Sponsors & Collaborators

• Michael A Belfort: lead
• Baylor College of Medicine: collaborator

Study Sites (1)

Texas Children's Hospital - Pavilion for Women

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Fetofetal Transfusion

Condition Hierarchy (Ancestors)

Anemia, Neonatal; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Michael A Belfort, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chairman and Professor

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: September 5, 2023
• Study Start: April 1, 2025
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

US (1)