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

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

Study Overview

• Status: Recruiting
• Conditions: Neural Tube Defects
• Intervention / Treatment: Device: Modified Surgical Instruments/Devices (Sheaths and Irrigator)

Detailed Description

All patients who choose to undergo fetoscopic neural tube defect repair at Texas Children's Fetal Center will be offered participation in this research study by study investigators. Description of study rationale and design and a focused interview by the study coordinator to afford potential participants a formal opportunity to examine what they have learned about the research study in the course of their evaluation and discuss how they feel about enrolling in the research study. Once the patient is deemed eligible the informed consent process will be reviewed. If patients elect to participate in the study, informed consent will be obtained, and patients provided a copy of the signed consent.

Fetoscopic Procedure: The fetoscopic open neural tube defect repair procedure will be performed with the same technique in this protocol as the investigators did in the previous protocols under this IDE (NCT02230072 and NCT03794011) in terms of exteriorization of the uterus, preparation for the fetoscopic repair and repair of the open neural tube defect. This involves release of the placode, dissection of the surrounding skin, development of myofascial flaps on either side of the defect, placement of a patch to be laid on top of the placode prior to closure of the myofascial flaps, suture of the flaps over the freed placode and patch and attempted primary closure of the defect using available skin. If necessary, the surgeons will use relaxing incisions or a skin patch to provide additional mobility to the skin to be closed over the defect. If the surgeons are unable to close the skin primarily despite best fetoscopic efforts, the option of performing/completing the repair as an open procedure exists and will be offered to the subject.

Follow-Up: The investigators will follow patients for the immediate post-procedure period (until they leave the OR).

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael A Belfort, MD; Phone Number: 832-826-7375; Email: belfort@bcm.edu
• Study Contact Backup: Name: Becky Johnson; Phone Number: 832-826-7451; Email: rj2@bcm.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Texas Childrens Hospital - Pavilion for Women
      • Principal Investigator: Michael A Belfort, M.D.
      • Sub-Investigator: Timothy Lee, M.D.
      • Sub-Investigator: Magdalena Sanz Cortes, M.D., PhD
      • Sub-Investigator: Ahmed Nassr, M.D.
      • Sub-Investigator: Alice King, M.D.
      • Sub-Investigator: Roopali Donepudi, MD
      • Sub-Investigator: Sundeep Keswani, MD
      • Contact: Michael A Belfort, MD; Phone Number: 832-826-7375; Email: belfort@bcm.edu
      • Contact: Becky Johnson; Phone Number: 832-826-7451; Email: rj2@bcm.edu
      • Sub-Investigator: William Whitehead, MD, MPH
      • Sub-Investigator: Luc Joyeux, MD, PhD
      • Sub-Investigator: Kwansoo Chun, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients who elect to undergo fetoscopic neural tube defect repair

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Modified Devices in fetoscopic NTD repair; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Michael A Belfort
• Collaborators: Baylor College of Medicine
• Investigators: Principal Investigator: Michael A Belfort, MD, Baylor College of Medicine and Texas Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: November 28, 2022
• First Submitted That Met QC Criteria: January 3, 2023
• First Posted (Actual): January 5, 2023

Study Record Updates

• Last Update Posted (Estimated): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: spina bifida; MMC; myelomeningocele; NTD; neural tube defect
• Additional Relevant MeSH Terms: Nervous System Diseases; Congenital Abnormalities; Nervous System Malformations; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Spinal Dysraphism; Meningomyelocele; Neural Tube Defects; Equipment and Supplies
• Other Study ID Numbers: H-51509

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No