Treatment of Rectovaginal Crohn's Fistula by Combination of TAAM Injection and Biological Plug Pl… (NCT06813768) | Clinical Trial Compass
SuspendedNot Applicable
Treatment of Rectovaginal Crohn's Fistula by Combination of TAAM Injection and Biological Plug Placement
Stopped: Study currently suspended due to device-related issues
Italy3 participantsStarted 2023-01-07
Plain-language summary
Interventional, prospective, randomized, controlled, double blind, parallel groups, nonprofit, single center trial
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Confirmed Crohn's disease
* presence of recto-vaginal fistula refractory to standard treatment (surgical drainage of sepsis and treatment with biological drg for at least 12 months)
* The patient has received, understood and signed the informed consent to actively participate in the study.
* The patient is able to understand the conditions of the study and to participate for the whole duration.
Exclusion Criteria:
* presence of oostomy
* Patients with active HIV, hepatitis C (HCV), hepatitis B (HBV), tuberculosis or other uncontrolled septic conditions.
* Patients who present technical difficulties, in the opinion of the investigator, in safely recovering the amount of adipose tissue necessary for the procedure.
* Patients with abdominal localization of Crohn's disease who may require general surgery during the study.
* Patients with active oncological or lymphoproliferative diseases
* Pregnant or breastfeeding women
What they're measuring
1
combined remission
Timeframe: 24 weeks
Trial details
NCT IDNCT06813768
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna