MedTrace Logo

RESTOREGI Study: Regenerative Endoscopic Stromal Therapy: Outcomes and Risk Factor Evaluation in GI Fistulas

NCT07661043 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-06-24

No results posted yet for this study

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.

Conditions

  • Fistula
  • Regenerative Medicine
  • Stromal Vascular Fraction

Interventions

PROCEDURE

Endoscopic tSVF-EM Therapy

Autologous adipose tissue will be harvested using standard liposuction techniques and mechanically processed to obtain total stromal vascular fraction-enriched microfragmented adipose tissue (tSVF-EM). The processed tissue will be injected endoscopically into the margins and/or tract of benign gastrointestinal fistulas according to institutional regenerative endoscopy protocols. Adjunctive endoscopic therapies, including argon plasma coagulation (APC), fistula tract abrasion or curettage, clips, over-the-scope clips (OTSC), endoscopic suturing, or stent placement, may be performed at the discretion of the treating physician. Repeat tSVF-EM treatment sessions may be undertaken based on clinical response and persistence of the fistula.

Sponsors & Collaborators

  • Asian Institute of Gastroenterology, India

    lead OTHER

Principal Investigators

  • Goutham R Katukuri, MBBS, MD, DM · AIG Hospitals

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-15
Primary Completion
2027-08-31
Completion
2027-08-31

Countries

  • India

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07661043 on ClinicalTrials.gov