Status:
RECRUITING
Endoscopic Injection of Autologous, Activated and Emulsified Fat in Chronic Fistulas of the Gastrointestinal Tract and Pelvic Organs
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Fistula Repair
Eligibility:
All Genders
18+ years
Brief Summary
Fistulas are defined as pathologic communications between two epithelialized surfaces and represent a complex nosologic entity that often exposes the patient to life-threatening or disabling sequelae....
Eligibility Criteria
Inclusion
- Male or female patients having a diagnosis of chronic fistula (diagnosis at least 3 months before the enrollment) of the pelvic organs and/or the gastrointestinal tract of any type, being symptomatic and/or impacting the quality of life.
- Age of at least 18 years.
- Able to comply with study requirements and understand and sign the Informed Consent Form.
Exclusion
- Impaired hemostasis or any contraindication to perform endoscopy or liposuction.
- Any contraindication to perform deep sedation or general anesthesia.
- Woman being pregnant at the time of the procedure.
- Malignancy in active treatment.
- Any health issue that might put the patient at risk if the treatment is performed is judged by the investigator.
Key Trial Info
Start Date :
March 20 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 20 2027
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT06930079
Start Date
March 20 2025
End Date
December 20 2027
Last Update
April 18 2025
Active Locations (1)
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1
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy, 00168