Evaluation of the Efficacy and Safety of DMR Using the Revita® in Subjects With Inadequately Controlled Type 2 Diabetes
NCT ID: NCT04419779
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
NA
320 participants
INTERVENTIONAL
2021-03-08
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Duodenal Mucosal Resurfacing Sham (Sham)
Duodenal Mucosal Resurfacing Sham (Sham) treatment will include an upper endoscopic procedure similar to DMR treatment without hydrothermal ablation of the duodenal mucosa in patients with inadequately controlled type 2 diabetes.
Duodenal Mucosal Resurfacing (Sham)
The Sham procedure consists of placing the Revita® Catheter as described above into the duodenum for a minimum of 30 minutes and then removing it from the patient. Subjects who receive the Sham procedure are followed for 48 weeks post treatment and are offered cross over to undergo the DMR procedure at 48 weeks and are followed for further 48 weeks post treatment. Sham subjects who choose not to cross over are discontinued from the study.
Duodenal Mucosal Resurfacing (DMR)
Duodenal Mucosal Resurfacing (DMR) treatment will include hydrothermal ablation of the duodenal muscosa in an upper endoscopic procedure in patients with inadequately controlled type 2 diabetes.
Duodenal Mucosal Resurfacing (DMR)
The Fractyl DMR Procedure utilizes the Revita® Catheter to perform hydrothermal ablation of the duodenum. The Catheter is delivered trans-orally over a guide-wire to first inject saline to lift the sub-mucosal space, followed by an ablation of the duodenal mucosa. Subjects who receive the DMR treatment are followed for 48 weeks post treatment.
Interventions
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Duodenal Mucosal Resurfacing (DMR)
The Fractyl DMR Procedure utilizes the Revita® Catheter to perform hydrothermal ablation of the duodenum. The Catheter is delivered trans-orally over a guide-wire to first inject saline to lift the sub-mucosal space, followed by an ablation of the duodenal mucosa. Subjects who receive the DMR treatment are followed for 48 weeks post treatment.
Duodenal Mucosal Resurfacing (Sham)
The Sham procedure consists of placing the Revita® Catheter as described above into the duodenum for a minimum of 30 minutes and then removing it from the patient. Subjects who receive the Sham procedure are followed for 48 weeks post treatment and are offered cross over to undergo the DMR procedure at 48 weeks and are followed for further 48 weeks post treatment. Sham subjects who choose not to cross over are discontinued from the study.
Eligibility Criteria
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Inclusion Criteria
1. Males and non-pregnant non-lactating females
2. Age between 21 and 70 years (both inclusive)
3. Subjects on at least one glucose lowering agent (GLA) with no changes in GLA medications or dosing for at least 12 weeks prior to the screening visit
Permitted GLAs include:
* Metformin,
* GLP-1 RA including dual peptide agonists and related molecules (e.g., GLP-1/GIP RA),
* DPP-4i,
* TZDs,
* SGLT2is,
* SUs,
* Meglitinides,
* Insulin (basal or basal combined with short-acting), up to a total of 100 units daily
4. HbA1c of 7.5%-10% (both inclusive)
5. BMI \>24 to ≤40 kg/m2
6. WOCBP should have a negative urine beta hCG pregnancy test and must agree to use two of the established contraceptive methods throughout the study duration
7. Able to sign an ICF and comply with study requirements
4. Recurrent or severe urinary tract or genital mycotic infections or history of GU infection within 4 weeks prior to informed consent, for those subjects on SGLT-2
5. ALT or AST \>3 times upper limit of normal (ULN) for the reference range, as determined by the central laboratory at screening visit. Patients with NAFLD are eligible if their ALT level is ≤3.0 times the ULN.
6. Use of an investigational drug within 1 month or 5 half-lives (whichever is longer) before screening
7. Diagnosed with type 1 diabetes or with a recent history of DKA within one year prior to screening
8. Ketosis-prone T2D
9. Known diabetes related non-healing ulcers or amputations (with the exception of a finger or toe amputation occurring \> 1 year prior to screening.
10. History of more than 1 severe hypoglycemia episode or hypoglycemia unawareness within the last 6 months
11. Clinically significant hypoglycemia occurring during the run-in period, defined as a) 2 or more glucose alert values of ≤70 mg/dL (3.9 mmol/L) unless a clear, correctable, precipitating factor can be identified; b) clinically significant hypoglycemia with self-monitored or laboratory plasma glucose level \<54 mg/dL (3.0 mmol/L); or c) severe hypoglycemic episode requiring third party assistance
12. Known intestinal autoimmune disease including celiac disease, ulcerative colitis, Crohn's disease, lupus erythematosus, scleroderma, or other autoimmune connective tissue disorder that affects the small intestine
13. Secondary hypothyroidism or inadequately controlled primary hypothyroidism (thyroid stimulating hormone \[TSH\] value outside the normal range at screening as determined by the central laboratory).
14. Known thyroid cancer or hyperthyroidism with treatment within the past 12 months or inadequately controlled hyperthyroidism (TSH value outside the normal range at screening as determined by the central laboratory).
15. An uncontrolled endocrine condition such as multiple endocrine neoplasia (except T2D)
16. Known structural or functional disorder of the esophagus including any swallowing disorder, esophageal chest pain disorders, drug-refractory esophageal reflux symptoms, or active and uncontrolled gastroesophageal reflux disease (GERD) (defined as Los Angeles Grade C or D esophagitis)
17. Known structural or functional disorder of the stomach including active gastric ulcer, chronic gastritis, gastric varices, hiatal hernia (a large hiatal hernia or type II and higher paraoesophageal hernia), cancer, or any other disorder of the stomach
18. Previous GI surgery that could affect the ability to treat the duodenum such as subjects who have had a Billroth 2, Roux-en-Y gastric bypass, gastric sleeve, or other similar procedures or conditions
19. Known history of chronic pancreatitis or a recent history of acute pancreatitis within the past year
20. Presence of acute or chronic active hepatitis B or C (except if hepatitis C is cured) or cirrhosis, hepatic decompensation/acute liver disease during the last 6 months, or alcoholic or autoimmune chronic hepatitis
21. Symptomatic gallstones, symptomatic kidney stones, or acute cholecystitis
22. Clinically active systemic infection
23. Known immunocompromised status including but not limited to individuals who have undergone organ transplantation, chemotherapy, or radiotherapy within the past 12 months; have clinically significant leukopenia; are positive for the human immunodeficiency virus (HIV); are on potential immunosuppressants; or individuals whose immune status makes the subject a poor candidate for clinical trial participation in the opinion of the investigator
24. Known active malignancy or partial remission from clinically significant malignancy within the past 5 years (except basal or squamous cell skin cancer, carcinoma in situ, those who received curative treatment and are in complete remission for 5 years, or if the subject is confirmed as cancer free)
25. Known active coagulopathy or current upper gastro-intestinal bleeding conditions such as ulcers, gastric varices, strictures, or congenital or acquired intestinal telangiectasia
26. Known cases of sickle cell anemia, thalassemia, or conditions that affect red blood cell (RBC) turnover such as a recent blood transfusion within 90 days. Current persistent anemia, defined as hemoglobin \<10g/dL
27. Use of anticoagulation therapy (e.g., warfarin, coumadin, or novel oral anticoagulants \[NOACs\]) or anti-platelet agents (e.g., thienopyridine) which cannot be discontinued for 5-7 days or 2 drug half-lives before the procedure
28. Use of systemic glucocorticoids (excluding topical or ophthalmic applications or inhaled forms) for more than 10 consecutive days within 90 days prior to screening
29. Use of non-GLA drugs known to affect GI motility (e.g., metoclopramide)
30. Known moderate to severe chronic kidney disease (CKD) with an estimated glomerular filtration rate (eGFR) of \<45 mL/min/1.73m2 (estimated by Modification of Diet in Renal Disease \[MDRD\]), end-stage renal failure, or on dialysis
31. History of myocardial infarction, stroke, transient ischemic attack, coronary artery intervention, CHF exacerbation, or any other major cardiac event requiring hospitalization within the last 6 months prior to screening or any cardiac history that would deem subject not eligible for anesthesia (unless documented clearance by cardiologist and/or treating endoscopy team)
32. History of new or worsening signs or symptoms of coronary heart disease (CHD) within the last 3 months
33. Known case of severe peripheral vascular disease, defined as AMA Criteria Class 1 or greater75 (Appendix 19.8)
34. Known case of symptomatic heart failure with reduced ejection fraction (NYHA Class II-IV) requiring pharmacologic therapy to control symptoms
35. Clinically significant electrocardiogram (ECG) findings such as new clinically significant arrhythmia, ST segment changes, or other conduction disturbances that increase risk of heart disease and require intervention as determined by the investigator
36. Subjects who are at risk of pancreatitis, particularly those with a recent fasting triglyceride value of \>600 mg/dL within the past 3 months
37. Actively participating in a weight-loss program and currently not in the maintenance phase
38. General contraindications to deep or conscious sedation, general anesthesia, high risk as determined by anesthesiologist (e.g., ASA score 4 or higher), or contraindications to upper GI endoscopy
39. History of substance use disorder based on the DSM-5 criteria76 within the last 12 months (American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition).
40. Use of weight loss medication such as Meridia, Xenical, over-the-counter weight-loss medications, or other prescribed medications used specifically for the purpose of weight loss
41. Use of dietary supplements or herbal preparations that may have unknown effects on glycemic control or risk of bleeding
42. Participating in another ongoing clinical trial of an investigational drug or device
43. History of non-adherence to treatment in the previous 6 months, as determined by the investigator based on patient history, HbA1c value, or drug accountability
44. Any other mental or physical condition which, in the opinion of the investigator, makes the subject a poor candidate for clinical-trial participation. Physical conditions assessed via endoscopy prior to participant study enrollment at visit 4 include, but not limited to:
1. Active and uncontrolled gastroesophageal reflux disease (GERD) defined as Los Angeles Grade C or D esophagitis
2. Abnormalities of the GI tract preventing endoscopic access to the duodenum
3. Anatomic abnormalities in the duodenum that would preclude the completion of the DMR procedure, including tortuous anatomy
4. Malignancy newly diagnosed by endoscopy
Exclusion Criteria
2. Known case of absolute insulin deficiency as indicated by clinical assessment or a fasting plasma C-peptide of \<0.6 ng/mL
45. Unwilling or unable to comply with study visits and other study procedures as required per protocol
46. Recovered from severe COVID-19 infection (requiring hospitalization) but with persistent long COVID-19 symptoms (i.e., the individual has not recovered for several weeks or months since the start of symptoms that were suggestive of COVID-19, irrespective if the individual was tested or not)
21 Years
70 Years
ALL
No
Sponsors
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Fractyl Health Inc.
INDUSTRY
Responsible Party
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Locations
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Helios CR, Inc
Phoenix, Arizona, United States
HonorHealth Research Institute
Scottsdale, Arizona, United States
Mayo Clinic Arizona
Scottsdale, Arizona, United States
Angel City Research , Inc.
Los Angeles, California, United States
UCLA Health
Los Angeles, California, United States
Care Access Santa Clarita
Newhall, California, United States
Hoag Hospital
Newport Beach, California, United States
Stanford University Medical Center
Redwood City, California, United States
Mills Peninsula Health Center
San Mateo, California, United States
Northeast Research Institute, Llc
Fleming Island, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
University of Miami
Miami, Florida, United States
West Orange Endocrinology
Ocoee, Florida, United States
Advent Health Orlando
Orlando, Florida, United States
Synexus Research
Orlando, Florida, United States
Northwestern Unviersity
Evanston, Illinois, United States
AHN - Avon
Avon, Indiana, United States
Investigators Research Group
Brownsburg, Indiana, United States
AHN- Franklin
Franklin, Indiana, United States
AHN - Greenfield
Greenfield, Indiana, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
AHN - Muncie
Muncie, Indiana, United States
University of Louisville
Louisville, Kentucky, United States
Tulane University
New Orleans, Louisiana, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Alcanza Clinical Research, LLC
Methuen, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Jefferson City Medical Group
Jefferson City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
IMA Clinical Research St. Louis
St Louis, Missouri, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Endocrine Associates of West Village
Long Island City, New York, United States
NYU Langone Gastroenterology Associates
New York, New York, United States
Synexus Clinical Research, New York
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Weill Cornell Medicine
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
M3 Wake Research
Raleigh, North Carolina, United States
AcellaCare Salisbury
Salisbury, North Carolina, United States
AcellaCare Piedmont
Statesville, North Carolina, United States
AcellaCare Wilmington
Wilmington, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Preferred PCP - Pittsburgh
Pittsburgh, Pennsylvania, United States
Preferred Primary Care Physicians
Pittsburgh, Pennsylvania, United States
Care Access Warwick
Warwick, Rhode Island, United States
Baylor St. Luke's Medical Center
Houston, Texas, United States
Biopharma Informatic, Llc
Houston, Texas, United States
Simcare Medical Research, Llc.
Sugar Land, Texas, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
West Virginia University
Morgantown, West Virginia, United States
Cliniques Universitaires de Bruxelles Hopital Erasme
Brussels, , Belgium
University College Dublin
Dublin, , Ireland
Italy Gemelli
Roma, , Italy
Universiteit Van Amsterdam Academisch Medisch Centrum
Amsterdam, , Netherlands
University Hospital Zurich
Zurich, , Switzerland
Cleveland Clinic London
London, England, United Kingdom
King's College Hospital
London, , United Kingdom
Countries
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Other Identifiers
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C-00044
Identifier Type: -
Identifier Source: org_study_id