Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

RESTOREGI Study: Regenerative Endoscopic Stromal Therapy: Outcomes and Risk Factor Evaluation in GI Fistulas (RESTORE-GI)

22 juni 2026 bijgewerkt door: Mohan Ramchandani, Asian Institute of Gastroenterology, India

PROSPECTIVE RISK FACTOR ANALYSIS OF CLINICAL OUTCOMES FOLLOWING ENDOSCOPIC tSVF-em THERAPY FOR BENIGN GASTROINTESTINAL FISTULAS - RESTOREGI Study

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Benign gastrointestinal fistulas are abnormal communications between the gastrointestinal tract and adjacent organs or the skin that can result in significant morbidity, prolonged hospitalization, impaired quality of life, and repeated therapeutic interventions. Chronic fistulas are characterized by persistent inflammation, fibrosis, impaired perfusion, and defective tissue regeneration, all of which may contribute to failure of conventional closure techniques and recurrent disease.

Endoscopic regenerative therapy using autologous total stromal vascular fraction-enriched microfragmented adipose tissue (tSVF-EM) has emerged as a novel therapeutic approach for the management of complex gastrointestinal defects. Following adipose tissue harvest and mechanical processing, tSVF-EM contains a heterogeneous population of stromal and regenerative cells, extracellular matrix components, and bioactive factors that may promote angiogenesis, immunomodulation, tissue remodeling, and wound healing. Endoscopic delivery of this material directly into the fistula margins aims to create a biologically favorable environment for durable tissue repair.

Early clinical experience with regenerative endoscopic therapies has demonstrated technical feasibility and encouraging healing outcomes in selected patients with benign gastrointestinal fistulas. However, considerable variability in treatment response exists, and factors associated with successful healing remain poorly understood. Improved understanding of patient-related, fistula-related, and procedural determinants of treatment success may facilitate better patient selection, optimize procedural planning, guide the use of adjunctive therapies, and improve overall clinical outcomes.

The RESTOREGI study is a prospective, single-center, real-world cohort study designed to evaluate clinical outcomes following endoscopic tSVF-EM therapy in patients with benign gastrointestinal fistulas. Standardised data will be collected regarding patient characteristics, fistula anatomy and etiology, inflammatory and nutritional status, and procedural factors associated with regenerative endotherapy. The study is intended as an exploratory, hypothesis-generating investigation to identify clinically meaningful factors associated with fistula healing and to establish prospective safety and effectiveness data in this emerging field of regenerative endoscopy.

Findings from this study are expected to provide foundational evidence for future multicenter studies and contribute to the development of evidence-based patient selection and treatment strategies for regenerative management of benign gastrointestinal fistulas.

Studietype

Ingrijpend

Inschrijving (Geschat)

50

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Indië
    • Telangana
      • Hyderabad, Telangana, Indië, 500075
        • AIG Hospitals
        • Contact:
        • Hoofdonderzoeker:
          • Goutham R Katukuri, MBBS, MD, DM

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: NVT
  • Interventioneel model: Sequentiële toewijzing
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Endoscopic tSVF-EM Therapy for Benign Gastrointestinal Fistulas
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
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Composite Fistula Healing at 6 Months
Tijdsspanne: 6 months following the first tSVF-EM treatment session

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of tSVF-EM Treatment Sessions Required for Healing
Tijdsspanne: Up to 12 months after first treatment session
Total number of endoscopic tSVF-EM treatment sessions required to achieve composite fistula healing.
Up to 12 months after first treatment session
Time to Fistula Healing
Tijdsspanne: Up to 12 months after first treatment session
Time from the first tSVF-EM treatment session to achievement of composite fistula healing, defined as clinical resolution of fistula output and objective confirmation of closure by endoscopy or imaging.
Up to 12 months after first treatment session
Fistula Recurrence Rate
Tijdsspanne: 12 months after first treatment session
Proportion of participants who develop recurrence of a previously healed fistula, defined as reappearance of clinical drainage and/or objective evidence of fistula reopening after documented healing.
12 months after first treatment session
Treatment-Related Adverse Events
Tijdsspanne: From treatment initiation through 12 months of follow-up
Incidence, type, severity, and outcome of adverse events related to adipose tissue harvest, endoscopic intervention, sedation/anesthesia, and delayed infectious complications. Adverse events will be graded according to the ASGE Lexicon classification system.
From treatment initiation through 12 months of follow-up
Overall Clinical Healing Rate
Tijdsspanne: 12 months after first treatment session
Proportion of treated fistulas achieving clinical healing during the study period.
12 months after first treatment session
Need for Additional Endoscopic or Surgical Intervention
Tijdsspanne: 12 months after first treatment session
Proportion of participants requiring alternative endoscopic therapies, radiologic interventions, or surgery because of persistent or recurrent fistula despite tSVF-EM therapy.
12 months after first treatment session

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Asian Institute of Gastroenterology, India

Onderzoekers

  • Hoofdonderzoeker: Goutham R Katukuri, MBBS, MD, DM, AIG Hospitals

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

15 juni 2026

Primaire voltooiing (Geschat)

31 augustus 2027

Studie voltooiing (Geschat)

31 augustus 2027

Studieregistratiedata

Eerst ingediend

5 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

18 juni 2026

Eerst geplaatst (Werkelijk)

22 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

24 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

22 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • tSVF-EM; Version:02

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

ndividual participant-level data collected during this study will not be made publicly available. De-identified aggregate study results may be published in scientific journals and presented at scientific meetings.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren