NCT06813768

Treatment of Rectovaginal Crohn's Fistula by Combination of TAAM Injection and Biological Plug Placement

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rectovaginal Fistula
• Crohn Disease

Interventions

Type	Name	Description
DEVICE	Microfractured adipose tissue injection and plug placement	surgery + infiltration of micro-fractured autologous adipose tissue at the level of the internal orifice and placement of a biological prosthesis

Timeline

• Start date: 2023-01-07
• Primary completion: 2024-03-30
• Completion: 2025-03-30
• First posted: 2025-02-07
• Last updated: 2025-02-07

Locations

1 site across 1 country: Italy