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Minimally Invasive Fetoscopic Regenerative Repair of Spina Bifida - A Pilot Study

NCT03936322 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2025-02-24

Study results available
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Summary

Researchers are studying a new minimally invasive technique (fetoscopic repair) for repair of spina bifida (MMC) during the second trimester of pregnancy. Researchers are trying to determine if this less invasive surgical approach will have less risk to the mother and at the same time adequate closure of the fetal spina bifida defect.

Conditions

  • Spina Bifida
  • Myelomeningocele
  • Neural Tube Defects

Interventions

DEVICE

Minimally invasive fetoscopic repair of MMC

Uses a technique to open your belly (skin, muscles and abdomen) without opening the uterus, except for a small puncture, to repair the fetal spina bifida defect during the second trimester of pregnancy.

Sponsors & Collaborators

  • Mayo Clinic

    collaborator OTHER

  • Rodrigo Ruano

    lead OTHER

Principal Investigators

  • Rodrigo Ruano, M.D., Ph.D. · University of Miami

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-07
Primary Completion
2024-06-30
Completion
2024-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT03936322 on ClinicalTrials.gov