Recruiting

Observational Study

Sponsor:

Michael A Belfort

Code:

NCT05672849

Conditions

Neural Tube Defects

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Modified Surgical Instruments/Devices (Sheaths and Irrigator)

Study Details

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

Study ID

NCT05672849

Start date

Nov 14, 2022

Status verified date

Dec, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Modified Devices in fetoscopic NTD repair

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

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.

Primary outcome measure

  • Number of adverse events [ Time Frame: Immediate Post-Procedure period (until the leave the OR) ]
  • Number of device defects, malfunctions, or failures [ Time Frame: Immediate Post-Procedure period (until the leave the OR) ]

Central Contacts and Locations

Central contacts

Michael A Belfort, MD

832-826-7375belfort@bcm.edu

Becky Johnson

832-826-7451rj2@bcm.edu

Locations

Texas Childrens Hospital - Pavilion for Women

Recruiting

Houston, Texas, United States, 77030

Contacts

Michael A Belfort, MD

832-826-7375belfort@bcm.edu

Becky Johnson

832-826-7451rj2@bcm.edu

Principal Investigator:

Michael A Belfort, M.D.

More Information

Sponsor

Michael A Belfort

Last update posted

Dec 15, 2025

Last verified

Dec, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Michael A Belfort on 2025-12-15.