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

NCT ID: NCT05672849

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-14
• Study Completion Date: 2027-12-31

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.

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).

Conditions

Neural Tube Defects

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Modified Devices in fetoscopic NTD repair

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

Group Type: EXPERIMENTAL

Modified Surgical Instruments/Devices (Sheaths and Irrigator)

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Baylor College of Medicine

OTHER

Sponsor Role: collaborator

Michael A Belfort

OTHER

Sponsor Role: lead

Responsible Party

Michael A Belfort

Chairman and Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Michael A Belfort, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine and Texas Children's Hospital

Locations

Texas Childrens Hospital - Pavilion for Women

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Michael A Belfort, MD

Role: CONTACT

belfort@bcm.edu

832-826-7375

Becky Johnson

Role: CONTACT

rj2@bcm.edu

832-826-7451

Facility Contacts

Michael A Belfort, MD

Role: primary

belfort@bcm.edu

832-826-7375

Becky Johnson

Role: backup

rj2@bcm.edu

832-826-7451

Other Identifiers

H-51509

Identifier Type: -

Identifier Source: org_study_id