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

NCT05672849 | Recruiting DMC FDA Device

• 1 other identifier: H-51509
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

myelomeningocele; MMC; NTD; neural tube defect; spina bifida

Outcome Measures

Primary Outcomes (2)

• Number of adverse events

  Number of adverse events associated with the investigational device

  Immediate Post-Procedure period (until the leave the OR)

• 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 (until the leave the OR)

Study Arms (1)

Modified Devices in fetoscopic NTD repair

EXPERIMENTAL

Single arm study. All patients will undergo fetoscopic NTD repair with the use of the modified devices.

Device: Modified Surgical Instruments/Devices (Sheaths and Irrigator)

Interventions

Modified Surgical Instruments/Devices (Sheaths and Irrigator) DEVICE

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.

Modified Devices in fetoscopic NTD repair

Eligibility Criteria

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

You may qualify if:

• Patients who elect to undergo fetoscopic neural tube defect repair

You may not qualify if:

• Patients who do not elect to undergo fetoscopic neural tube defect repair

Sponsors & Collaborators

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

Study Sites (1)

Texas Childrens Hospital - Pavilion for Women

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Neural Tube Defects; Meningomyelocele; Spinal Dysraphism

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Michael A Belfort, MD

  Baylor College of Medicine and Texas Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael A Belfort, MD

CONTACT

832-826-7375; belfort@bcm.edu

Becky Johnson

CONTACT

832-826-7451; rj2@bcm.edu

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: November 28, 2022
• First Posted: January 5, 2023
• Study Start: November 14, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

US (1)