NCT04362592

In-Utero Endoscopic Correction of Spina Bifida

In-Utero Endoscopic Correction of Spina Bifida: Laparotomy-Assisted or Percutaneous

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: University of Southern California · Academic / Other
• Sex: Female
• Age: 18 Years – 52 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the feasibility and effectiveness of performing fetoscopic surgical correction of fetal spina bifida. Two surgical approaches will be utilized: the percutaneous technique versus the laparotomy/uterine exteriorization technique.

Conditions

• Neural Tube Defects
• Spina Bifida
• Myelomeningocele

Interventions

Type	Name	Description
DEVICE	In Utero Endoscopic Correction of Myelomeningocele IDE - Percutaneous Technique	The percutaneous approach uses endoscopes through a closed maternal abdomen and closed uterus to perform the spina bifida correction.
DEVICE	In Utero Endoscopic Correction of Myelomeningocele IDE - Laparotomy/Uterine Exteriorization Technique	The laparotomy/uterine exteriorization technique uses endoscopes through an open abdomen and closed, exteriorized uterus to perform the spina bifida correction.

Timeline

• Start date: 2018-11-02
• Primary completion: 2026-06-01
• Completion: 2031-10-31
• First posted: 2020-04-27
• Last updated: 2025-03-28

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study