Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-28 @ 2:13 PM
Study NCT ID:
NCT00971269
Status:
UNKNOWN
Last Update Posted:
2009-09-03
First Post:
2009-09-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study of NASHA/Dx Gel for Fecal Incontinence
Sponsor:
Uppsala University Hospital
Organization:
Study Overview
Official Title:
A Pilot Study of Intersphincteric Injection of NASHA/Dx Gel for Fecal Incontinence
Status:
UNKNOWN
Status Verified Date:
2009-09
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:
None
Brief Summary:
The study is an open, prospective, single-site study where 16 patients suffering from fecal incontinence will be included. Change in fecal incontinence episodes after intersphincteric injection of NASHA/Dx gel 4x2 ml and retreatment 4x2 ml after 4 weeks will be measured.
Detailed Description:
None
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?: