Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-24 @ 3:51 PM
Study NCT ID:
NCT04362592
Status:
RECRUITING
Last Update Posted:
2025-03-28
First Post:
2020-03-24
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
In-Utero Endoscopic Correction of Spina Bifida
Sponsor:
University of Southern California
Organization:
Study Overview
Official Title:
In-Utero Endoscopic Correction of Spina Bifida: Laparotomy-Assisted or Percutaneous
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: