Safety & Effectiveness of Duodenal Mucosal Resurfacing (DMR) Using the Revita™ System in Treatment of Type 2 Diabetes
Randomized, Double-Blind, Sham-Controlled, Prospective, Multi-Center Pilot Study to Evaluate the Safety and Effectiveness of Duodenal Mucosal Resurfacing Using the Revita™ System in the Treatment of Type 2 Diabetes
1 other identifier
interventional
9
1 country
6
Brief Summary
The Revita™ System is being investigated to assess the ability to improve glycemic control in conjunction with diet and exercise in patients with Type 2 diabetes who are inadequately controlled with oral anti-diabetic medications. The purpose of this study is to demonstrate the safety and effectiveness of the Fractyl DMR Procedure using the Revita™ System compared to a sham procedure. At 24 weeks, subjects randomized to the DMR procedure be continued to be followed per protocol till 48 Weeks and the Sham treatment arm will be offered to cross over to receive the DMR treatment and will be followed per protocol for 24 weeks post treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable type-2-diabetes
Started Sep 2018
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2018
CompletedFirst Posted
Study publicly available on registry
August 31, 2018
CompletedStudy Start
First participant enrolled
September 28, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 10, 2020
CompletedResults Posted
Study results publicly available
July 26, 2022
CompletedFebruary 14, 2024
February 1, 2024
1.9 years
August 24, 2018
March 25, 2022
February 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Hemoglobin A1c (HbA1c)
Change in HbA1c from baseline in DMR vs Sham groups
24 weeks post procedure
Study Arms (2)
Duodenal Mucosal Resurfacing (DMR)
ACTIVE COMPARATORDuodenal Mucosal Resurfacing (DMR) treatment will include hydrothermal ablation of the duodenal mucosa in an upper endoscopic procedure in patients with type 2 diabetes.
Duodenal Mucosal Resurfacing Sham (Sham)
SHAM COMPARATORDuodenal 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 type 2 diabetes.
Interventions
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 DRM treatment are followed for 48 weeks while Sham subjects who cross over and undergo the DMR procedure at 24 weeks are followed for further 24 weeks post treatment. Sham subjects who choose not to cross over are discontinued from the study.
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.
Eligibility Criteria
You may qualify if:
- Men and non-pregnant women 28-65 years of age
- Diagnosed with T2D for at least 3 years
- A1C of 7.5 - 9.5% (59-80 mmol/mol)
- BMI ≥ 28 and ≤ 40 kg/m2
- Agree to use an additional glucose-lowering treatment (eg, liraglutide, other OAD with the exception of glyburide) if recommended by the study investigator in case of persistent hyperglycemia.
- Agree not to donate blood during their participation in the study
- Able to comply with study requirements and understand and sign the Informed Consent Form
- Women of childbearing potential (WOCBP) must be using two acceptable methods of contraception throughout the study
- Women must not be breastfeeding
You may not qualify if:
- Diagnosed with Type 1 Diabetes (T1D)
- History of diabetic ketoacidosis or hyperosmolar nonketotic coma
- Probable insulin production failure, defined as fasting C Peptide serum \<1 ng/mL (333pmol/l)
- Previous use of any types of insulin for \>1 month (at any time, except for treatment of gestational diabetes)
- Current use of injectable medications for diabetes (insulin, GLP-1RA)
- Current use of glyburide, a sulfonylurea (SU) glucose-lowering drug for diabetes
- Hypoglycemia unawareness or a history of severe hypoglycemia (more than 1 severe hypoglycemic event, as defined by need for third-party-assistance, in the last year)
- Known autoimmune disease, including but not limited to celiac disease, or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
- Previous GI surgery that could limit treatment of the duodenum such as Bilroth 2, Roux-en-Y gastric bypass, or other similar procedures or conditions
- History of chronic or acute pancreatitis
- History of diabetic gastroparesis
- Known active hepatitis or active liver disease
- Acute gastrointestinal illness in the previous 7 days
- Known history irritable bowel syndrome, radiation enteritis or other inflammatory bowel disease, such as Crohn's disease
- Known history of a structural or functional disorder of the esophagus that may impede passage of the device through the gastrointestinal tract or increase risk of esophageal damage during an endoscopic procedure, including Barrett's esophagus, esophagitis, dysphagia, achalasia, stricture/stenosis, esophageal varices, esophageal diverticula, esophageal perforation, or any other disorder of the esophagus
- +42 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Florida Hospital / TRANSLATIONAL RESEARCH INSTITUTE FOR METABOLISM AND DIABETES (TRI)
Orlando, Florida, 32804, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
University of Pennsylvania - Penn Metabolic Medicine
Philadelphia, Pennsylvania, 19104, United States
UTHealth
Houston, Texas, 77030, United States
Texas Diabetes Institute
San Antonio, Texas, 78229, United States
Related Publications (1)
Busch CBE, Meiring S, van Baar ACG, Gastaldelli A, DeFronzo R, Mingrone G, Hagen M, White K, Rajagopalan H, Nieuwdorp M, Bergman JJGHM. Insulin sensitivity and beta cell function after duodenal mucosal resurfacing: an open-label, mechanistic, pilot study. Gastrointest Endosc. 2024 Sep;100(3):473-480.e1. doi: 10.1016/j.gie.2024.01.031. Epub 2024 Jan 25.
PMID: 38280531DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Limitations of this pilot study include the small sample size and missing data due to COVID-19.
Results Point of Contact
- Title
- Sarah Hackett, Sr. Director of Clinical Operations
- Organization
- Fractyl Health, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2018
First Posted
August 31, 2018
Study Start
September 28, 2018
Primary Completion
August 10, 2020
Study Completion
August 10, 2020
Last Updated
February 14, 2024
Results First Posted
July 26, 2022
Record last verified: 2024-02