Treatment of Rectovaginal Crohn's Fistula by Combination of TAAM Injection and Biological Plug Placement
NCT06813768 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3
Last updated 2025-02-07
Summary
Interventional, prospective, randomized, controlled, double blind, parallel groups, nonprofit, single center trial
Conditions
- Rectovaginal Fistula
- Crohn Disease
Interventions
- 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
Sponsors & Collaborators
-
IRCCS Azienda Ospedaliero-Universitaria di Bologna
lead OTHER
Principal Investigators
-
Silvio Laureti, MD · IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-01-07
- Primary Completion
- 2024-03-30
- Completion
- 2025-03-30
Countries
- Italy
Study Locations
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