Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2025-12-25 @ 3:05 PM
Study NCT ID:
NCT06813768
Status:
SUSPENDED
Last Update Posted:
2025-02-07
First Post:
2025-01-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Rectovaginal Crohn's Fistula by Combination of TAAM Injection and Biological Plug Placement
Sponsor:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Organization:
Study Overview
Official Title:
Trattamento Delle Fistole Rettovaginali Di Crohn Mediante Combinazine Di Plug in Matrice Di Collagene (SURGIMEND®) Ed Infiltrazione Locale Di Tessuto Adiposo Autologo Microfratturato (LIPOGEMS®)
Status:
SUSPENDED
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study currently suspended due to device-related issues
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LIPOPLUG
Brief Summary:
Interventional, prospective, randomized, controlled, double blind, parallel groups, nonprofit, single center trial
Detailed Description:
The goal of this clinical trial is to compare, the efficacy of
* circumferential infiltration of microfractured autologous adipose tissue combined with the placement of a biological prosthesis in the fistula tract versus
* endoanal mucosal flap in terms of clinical and radiological healing (combined remission)
in patients with Crohn's rectovaginal fistulas refractory to standard treatment,
Secondary objectives are improvement of the clinical outcome (clinical remission, clinical response, failure), time elapsed between surgery and clinical outcome, onset of any recurrences, safety and improvement in quality of life.
* circumferential infiltration of microfractured autologous adipose tissue combined with the placement of a biological prosthesis in the fistula tract versus
* endoanal mucosal flap in terms of clinical and radiological healing (combined remission)
in patients with Crohn's rectovaginal fistulas refractory to standard treatment,
Secondary objectives are improvement of the clinical outcome (clinical remission, clinical response, failure), time elapsed between surgery and clinical outcome, onset of any recurrences, safety and improvement in quality of life.
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: