FistulaRESTORE-GINCT07661043
RESTOREGI Study: Regenerative Endoscopic Stromal Therapy: Outcomes and Risk Factor Evaluation in GI Fistulas
A study testing Endoscopic tSVF-EM Therapy in people with Fistula and Regenerative Medicine, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fistula, Regenerative Medicine, Stromal Vascular Fraction
- What is being tested?
- Endoscopic tSVF-EM Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- 15 Jun 2026to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site
AIG Hospitals
Hyderabad, Telangana, 500075
Nageshwar R Duvvur, MBBS, MD, DM, +914042444222, aigindia@yahoo.co.in
Goutham R Katukuri, MBBS, MD, DM
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Fistula, Regenerative Medicine, Stromal Vascular Fraction
- Being tested
- Endoscopic tSVF-EM Therapy
- Keywords
- Gastrointestinal fistula, Stromal vascular fraction, Endoscopic fistula closure, Regenerative endoscopy, Mesenchymal stromal cells
- Medical subject headings
- Fistula, Digestive System Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic tSVF-EM TherapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Endoscopic tSVF-EM Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months following the first tSVF-EM treatment session
Secondary outcomes (6)
Number of tSVF-EM Treatment Sessions Required for Healing
Total number of endoscopic tSVF-EM treatment sessions required to achieve composite fistula healing.
Measured: Up to 12 months after first treatment session
Time to Fistula Healing
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.
Measured: Up to 12 months after first treatment session
Fistula Recurrence Rate
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.
Measured: 12 months after first treatment session
Treatment-Related Adverse Events
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.
Measured: From treatment initiation through 12 months of follow-up
Overall Clinical Healing Rate
Proportion of treated fistulas achieving clinical healing during the study period.
Measured: 12 months after first treatment session
Need for Additional Endoscopic or Surgical Intervention
Proportion of participants requiring alternative endoscopic therapies, radiologic interventions, or surgery because of persistent or recurrent fistula despite tSVF-EM therapy.
Measured: 12 months after first treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohan Ramchandani, Asian Institute of Gastroenterology, India
- Investigators
- Goutham R Katukuri, MBBS, MD, DM, Principal investigator, AIG Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07661043
- Sponsor's protocol ID
- tSVF-EM; Version:02
- Acronym
- RESTORE-GI
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROSPECTIVE RISK FACTOR ANALYSIS OF CLINICAL OUTCOMES FOLLOWING ENDOSCOPIC tSVF-em THERAPY FOR BENIGN GASTROINTESTINAL FISTULAS - RESTOREGI Study
- ClinicalTrials.gov ID
- NCT07661043
- Acronym / sponsor ID
- RESTORE-GI / tSVF-EM; Version:02
- Conditions
- Fistula, Regenerative Medicine, Stromal Vascular Fraction
- Keywords
- Gastrointestinal fistula, Stromal vascular fraction, Endoscopic fistula closure, Regenerative endoscopy, Mesenchymal stromal cells
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic tSVF-EM Therapy for Benign Gastrointestinal Fistulas | Experimental | Procedure: Endoscopic tSVF-EM TherapyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic tSVF-EM TherapyAutologous 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. | Procedure or surgery | Endoscopic tSVF-EM Therapy for Benign Gastrointestinal Fistulas |
Primary outcome
Composite Fistula Healing at 6 Months
Time frame: 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 secondary outcomes
Number of tSVF-EM Treatment Sessions Required for Healing
Time frame: Up to 12 months after first treatment session
Time to Fistula Healing
Time frame: Up to 12 months after first treatment session
Fistula Recurrence Rate
Time frame: 12 months after first treatment session
Treatment-Related Adverse Events
Time frame: From treatment initiation through 12 months of follow-up
Overall Clinical Healing Rate
Time frame: 12 months after first treatment session
Need for Additional Endoscopic or Surgical Intervention
Time frame: 12 months after first treatment session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Goutham R Katukuri, MBBS, MD, DM principal investigator
AIG Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic tSVF-EM Therapy in people with Fistula and Regenerative Medicine, run by Asian Institute of Gastroenterology, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Goutham K Katukuri, MBBS, MD, DM (+919902305703, goutham.mge@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Fistula Healing at 6 Months (time frame: 6 months following the first tSVF-EM treatment session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.