NCT03856034

Laparotomy Versus Percutaneous Endoscopic Correction of Myelomeningocele

In Utero Endoscopic Correction of Myelomeningocele: Laparotomy Versus Percutaneous - A Pilot Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: USFetus · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the feasibility of a fetoscopic surgical technique for antenatal correction of fetal myelomeningocele. Two surgical approaches will be utilized. The percutaneous approach will be offered to participants with a posterior placenta. The laparotomy/uterine exteriorization approach will be offered to participants regardless of placental location.

Conditions

• Neural Tube Defects
• Spina Bifida
• Myelomeningocele
• Chiari Malformation

Interventions

Type	Name	Description
DEVICE	Fetoscopy	Patients will receive fetoscopic repair of myelomeningocele. Patients with an anterior placenta will undergo the laparotomy with uterine exteriorization approach. Patients with a posterior placenta will undergo the percutaneous approach (or, if patient prefers, the laparotomy with uterine exteriorization approach).

Timeline

• Start date: 2018-11-02
• Primary completion: 2020-11-02
• Completion: 2027-12-31
• First posted: 2019-02-27
• Last updated: 2019-11-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study