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

NCT07661043 | Not Yet Recruiting

• 1 other identifier: tSVF-EM; Version:02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Gastrointestinal fistula; Stromal vascular fraction; Endoscopic fistula closure; Regenerative endoscopy; Mesenchymal stromal cells

Outcome Measures

Primary Outcomes (1)

• Composite Fistula Healing at 6 Months

  Composite fistula healing is defined as the simultaneous achievement of: Clinical resolution of the fistula, characterized by the absence of fistula output, drainage, or symptoms attributable to the fistula; and Objective confirmation of closure demonstrated by either: Endoscopic evidence of complete closure of the fistula opening, or Radiological evidence of absence of contrast extravasation or fistulous communication on appropriate imaging studies. Participants meeting both criteria will be classified as having achieved successful fistula healing.

  6 months following the first tSVF-EM treatment session

Secondary Outcomes (6)

• Number of tSVF-EM Treatment Sessions Required for Healing

  Up to 12 months after first treatment session

• Time to Fistula Healing

  Up to 12 months after first treatment session

• Fistula Recurrence Rate

  12 months after first treatment session

• Treatment-Related Adverse Events

  From treatment initiation through 12 months of follow-up

• Overall Clinical Healing Rate

  12 months after first treatment session

Study Arms (1)

Endoscopic tSVF-EM Therapy for Benign Gastrointestinal Fistulas

EXPERIMENTAL

Participants with benign gastrointestinal fistulas will undergo endoscopic regenerative therapy using autologous total stromal vascular fraction-enriched microfragmented adipose tissue (tSVF-EM). Adjunctive endoscopic therapies including argon plasma coagulation, tract abrasion, clipping, over-the-scope clip placement, endoscopic suturing, or stenting may be performed at the discretion of the treating physician. Repeat tSVF-EM sessions are permitted according to clinical response.

Procedure: Endoscopic tSVF-EM Therapy

Interventions

Endoscopic tSVF-EM Therapy PROCEDURE

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.

Endoscopic tSVF-EM Therapy for Benign Gastrointestinal Fistulas

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

AIG Hospitals

Hyderabad, Telangana, 500075, India

Location

MeSH Terms

Conditions

Fistula; Digestive System Fistula

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Digestive System Diseases

Study Officials

• Goutham R Katukuri, MBBS, MD, DM

  AIG Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Goutham K Katukuri, MBBS, MD, DM

CONTACT

+919902305703; goutham.mge@gmail.com

Rajendra Patel, MBBS, MD, DM

CONTACT

+918152049069; doc.rajendrapatel@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 22, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)