Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-30 @ 10:37 PM
Study NCT ID:
NCT04169035
Status:
UNKNOWN
Last Update Posted:
2021-03-05
First Post:
2019-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The BD Odon DeviceTM for Assisted Vaginal Birth: a Feasibility Study to Investigate Safety and Efficacy
Sponsor:
Centre Hospitalier Universitaire de Besancon
Organization:
Study Overview
Official Title:
The BD Odon DeviceTM for Assisted Vaginal Birth: a Feasibility Study to Investigate Safety and Efficacy
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
RECRUITING
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:
ASSIST
Brief Summary:
Besancon ASSIST study will investigate if the BD Odon DeviceTM is safe, effective and acceptable to women and maternity staff for assisted vaginal birth.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: