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Safety and Efficacy of Devices Used in Fetoscopic Neural Tube Defect Repair Cases

NCT05672849 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-12-15

No results posted yet for this study

Summary

The purpose of the study is to evaluate the safety and efficacy of devices used in patients undergoing fetoscopic neural tube defect repair.

Conditions

  • Neural Tube Defects

Interventions

DEVICE

Modified Surgical Instruments/Devices (Sheaths and Irrigator)

Patients who choose to undergo fetoscopic surgery will be offered participation in this study. All patients will undergo a fetoscopic repair of the fetal open neural tube defect with the use of the modified devices in this study.

Sponsors & Collaborators

  • Baylor College of Medicine

    collaborator OTHER

  • Michael A Belfort

    lead OTHER

Principal Investigators

  • Michael A Belfort, MD · Baylor College of Medicine and Texas Children's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-14
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05672849 on ClinicalTrials.gov