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In-Utero Endoscopic Correction of Spina Bifida

NCT04362592 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-05-04

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • USFetus

    collaborator OTHER

  • University of Southern California

    lead OTHER

Principal Investigators

  • Ruben Quintero, MD · US Fetus

  • Ramen Chmait, MD · University of Southern California

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
52 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-02
Primary Completion
2025-06-29
Completion
2031-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04362592 on ClinicalTrials.gov