Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06425471
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-05-17
Brief Title:
A Prospective Study on the Efficacy of the Karl Storz Curved Fetoscope 11508aak and Its Straight Version 11506akk for In-utero Surgery
Sponsor:
The University of Texas Health Science Center Houston
Organization:
The University of Texas Health Science Center Houston
Study Overview
Official Title:
A Prospective Study on the Efficacy of the Karl Storz Curved Fetoscope 11508aak and Its Straight Version 11506akk for In-utero Surgery
Status:
RECRUITING
Status Verified Date:
2024-05
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 prospectively evaluate the efficacy of KARL STORZ curved fetoscope 11508AAK and its straight version 11506AAK for in-utero surgery
Detailed Description:
Outcome data will be compared to that of The Fetal Centers historical control group that underwent in-utero surgery without curved fetoscopes
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None