RESTOREGI Study: Regenerative Endoscopic Stromal Therapy: Outcomes and Risk Factor Evaluation in … (NCT07661043) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
RESTOREGI Study: Regenerative Endoscopic Stromal Therapy: Outcomes and Risk Factor Evaluation in GI Fistulas
India50 participantsStarted 2026-06-15
Plain-language summary
RESTOREGI Study Benign gastrointestinal fistulas are abnormal communications between the gastrointestinal tract and adjacent organs or the skin. Chronic fistulas are often difficult to treat because of persistent inflammation, fibrosis, impaired vascularity, and defective tissue regeneration. Endoscopic regenerative therapy using mechanically processed autologous total stromal vascular fraction-enriched microfragmented adipose tissue (tSVF-EM) has emerged as a novel therapeutic approach that may promote tissue repair through angiogenesis, immunomodulation, and regenerative signaling.
Although early clinical experience suggests promising healing outcomes, factors predicting successful fistula closure remain poorly understood. The RESTOREGI study is a prospective, single-center observational cohort study designed to identify patient-related, fistula-related, and procedural factors associated with successful healing following endoscopic tSVF-EM therapy in benign gastrointestinal fistulas. The study will also evaluate treatment safety, time to healing, recurrence rates, and the impact of procedural variables on outcomes.
Who can participate
Age range
18 Years
Sex
ALL
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:
* Age ≥18 years
* Confirmed benign gastrointestinal fistula involving the luminal gastrointestinal tract
* Fistula accessible for endoscopic evaluation and treatment
* Planned treatment with endoscopic tSVF-EM therapy, with or without adjunctive endoscopic therapies (argon plasma coagulation \[APC\], tract abrasion/curettage, clips, over-the-scope clips \[OTSC\], endoscopic suturing, or stent placement)
* Ability and willingness to provide written informed consent
* Willingness to comply with scheduled follow-up visits and study assessments
Exclusion Criteria:
* Perianal fistulas of any aetiology
* Inflammatory bowel disease-associated fistulas, including fistulas related to Crohn's disease or ulcerative colitis
* Malignancy-related fistulas
* Fistulas requiring primary oncologic surgical management
* Uncontrolled sepsis or undrained abscess at baseline (patients may become eligible following adequate drainage and clinical stabilisation)
* Contraindication to adipose tissue harvest, sedation, anaesthesia, or therapeutic endoscopy
* Pregnancy or lactation
* Severe coagulopathy not correctable prior to intervention
* Inability to provide informed consent
* Anticipated inability to complete study follow-up
* Participation in another interventional study that may influence fistula healing outcomes
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Composite Fistula Healing at 6 Months
Timeframe: 6 months following the first tSVF-EM treatment session