NCT03936322

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Rodrigo Ruano · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2019-05-07
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2019-05-03
• Last updated: 2025-02-24
• Results posted: 2025-02-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study