In-Utero Endoscopic Correction of Spina Bifida

This study is looking at two ways to perform surgery on babies in the womb who have spina bifida (a birth defect where the spinal cord doesn't form properly). The goal is to see if these surgeries are possible and how well they work. The two surgical methods are: the percutaneous technique, which uses small cameras through the mother's abdomen and uterus, and the laparotomy/uterine exteriorization technique, which involves opening the mother's abdomen and bringing the uterus outside to perform the surgery. You could join this study if you are a woman between 18 and 52 years old, and your baby has a specific type of spina bifida (myelomeningocele) and is between 19 and almost 28 weeks gestation. The main thing the researchers will measure is whether they can successfully complete the endoscopic procedure during the surgery itself. The current status of this study is unclear.

Study design
This interventional study plans to enroll 110 participants to evaluate two different surgical approaches for spina bifida correction.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at the time of surgery, so the follow-up period is not specified beyond that point.

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NCT04362592

In-Utero Endoscopic Correction of Spina Bifida

Active, Not Recruiting
NAAges 18–52InterventionalTreatment
University of Southern California
~110 participants
Updated 2026-05-04 on ClinicalTrials.gov
What's tested:In Utero Endoscopic Correction of Myelomeningocele IDE - Percutaneous TechniqueIn Utero Endoscopic Correction of Myelomeningocele IDE - Laparotomy/Uterine Exteriorization Technique

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Ability to perform the endoscopic procedure
Measured over At time of surgery
Neural Tube Defects
Spina Bifida
Myelomeningocele
2 sites across 2 states
California1
Florida1
  • Ruben Quintero, MD · PRINCIPAL_INVESTIGATOR · US Fetus
  • Ramen Chmait, MD · PRINCIPAL_INVESTIGATOR · University of Southern California

This trial hasn't published a contact. View it on ClinicalTrials.gov

  • Ability to perform the endoscopic procedureAt time of surgery

    Successful fetoscopic closure of the defect