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RECRUITING
NCT04362592
NA

In-Utero Endoscopic Correction of Spina Bifida

Sponsor: University of Southern California

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 52 Years

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2018-11-02

Completion Date

2031-10-31

Last Updated

2025-03-28

Healthy Volunteers

Yes

Interventions

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.

Locations (2)

Hollywood Presbyterian Medical Center

Los Angeles, California, United States

Wellington Regional Medical Center

Wellington, Florida, United States