Ignite Creation Date:
2025-12-26 @ 4:04 PM
Ignite Modification Date:
2025-12-28 @ 10:28 PM
Study NCT ID:
NCT01647906
Status:
COMPLETED
Last Update Posted:
2019-11-25
First Post:
2012-06-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long Term Safety and Efficacy of Solesta® Injectable Bulking Agent for the Treatment of Fecal Incontinence (SoFI)
Sponsor:
Bausch Health Americas, Inc.
Organization:
Study Overview
Official Title:
A Prospective, Single Arm, Multicenter, Observational Assessment of the Long Term Safety and Efficacy of Solesta® Injectable Bulking Agent for the Treatment of Fecal Incontinence (SoFI)
Status:
COMPLETED
Status Verified Date:
2019-11
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:
SoFI
Brief Summary:
The purpose of this observational study is to evaluate the safety and effectiveness of the Solesta Injectable Bulking Agent in the treatment of fecal incontinence through 3 years in a real world setting.
Detailed Description:
This observational study is to evaluate the safety and effectiveness of the Solesta Injectable Bulking Agent in the treatment of fecal incontinence through 3 years in a real world setting.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: