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

Conditions

• Neural Tube Defects

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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.

Study Details

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

Key Dates

Start date

Nov 14, 2022

Status verified

Dec 2025

Primary completion

Dec 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

100 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

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.

Primary Outcome Measure

Number of adverse events [ Time Frame: Immediate Post-Procedure period (until the leave the OR) ]

Central Contacts

• Michael A Belfort, MD
  832-826-7375
  [email protected]
• Becky Johnson
  832-826-7451
  [email protected]

Locations (1)

Find similar trials in Houston, TX

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