Injecting activated fat to treat chronic gastrointestinal and pelvic fistulas
Official title: Observational, Prospective Single-center Study on the Results of Endoscopic Injection of Autologous, Activated and Emulsified Fat in Chronic Fistulas of the Gastrointestinal Tract and Pelvic Organs
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT06930079 · Data updated 2026-11-12
This study is testing whether injecting activated fat can help people with long-lasting gastrointestinal and pelvic fistulas heal better and improve their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 43 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome) |
| Status | Recruiting |
| Started | March 20, 2025 |
| Main results expected | March 31, 2027 |
| Study ends | December 20, 2027 |
| Registry record updated | April 18, 2025 |
| Trial ID | NCT06930079 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with a diagnosis of chronic fistula affecting the gastrointestinal tract or pelvic organs.
✕Probably not a fit
Patients with active malignancies, impaired hemostasis, or contraindications to endoscopy or anesthesia may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on patients with chronic fistulas of the gastrointestinal tract and pelvic organs, which can lead to severe complications and impact quality of life. It aims to evaluate the effectiveness of endoscopic injection of autologous, activated, and emulsified fat as a potential treatment option. The study will include patients diagnosed with chronic fistulas for at least three months and will assess their symptoms and quality of life. The approach seeks to address the complex healing challenges associated with these conditions.
Why it matters
Potential benefit: If successful, this treatment could significantly improve healing outcomes and quality of life for patients suffering from chronic fistulas.
How similar studies have gone: While the approach of using autologous fat for healing is promising, the specific application in chronic fistulas is relatively novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where it's running
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy Recruiting
Study contacts
- Study coordinator: Ivo Boskoski
- Email: ivo.boskoski@policlinicogemelli.it
- Phone: 0630155701
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.