Trial to Evaluate Efficacy+Safety of Revita DMR Treatment Paradigm 1 and Retreatment in Type 2 Diabetes Patients

NCT06092476 | Recruiting DMC FDA Device

• 1 other identifier: NL82963.018.23
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate feasibility, safety, and efficacy of endoscopic DMR Treatment Paradigm 1 (compared to sham) and to evaluate feasibility, safety, and efficacy of re-treatment with DMR at 24 weeks (compared to baseline and a single DMR procedure) in patients with type 2 diabetes with non-insulin glucose lowering medications.

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 Diabetes; Duodenal ablation; Endoscopy; Duodenal Mucosal Resurfacing

Outcome Measures

Primary Outcomes (5)

• Safety endpoint

  Safety endpoint is evaluated 12 weeks post DMR and 12 weeks post retreatment with DMR \- Number (percentage) of patients experienced device and procedure-related Serious Adverse Events (SAEs), Unanticipated Device Effects (UADEs), Serious Adverse Device Effects (SADEs), Suspected Unexpected Serious Adverse Reaction (SUSARs)

  12 weeks post DMR and 12 weeks post retreatment with DMR

• Feasibility endpoint 1

  Feasibility endpoint is evaluated during and after the procedure: \- Number of ablations, whether a DMR was successful (\>3 ablations)

  During procedure

• Feasibility endpoint 2

  Feasibility endpoint is evaluated during and after the procedure: \- Procedure time, defined as time between catheter in and catheter out.

  During procedure

• Efficacy endpoint 1

  Efficacy is evaluated at 24 weeks compared to baseline and sham: \- Mean change in Fasting Plasma Glucose (FPG)/Flash Glucose Monitoring (FGM)

  24 weeks post DMR/sham

• Efficacy endpoint 2

  Efficacy is evaluated at 24 weeks compared to baseline and sham: \- Change in HbA1c

  24 weeks post DMR/sham

Secondary Outcomes (20)

• Secondary safety endpoint

  Through study completion, an average of 1 or 1,5 years

• Efficacy endpoint 1: mean change in HbA1c

  Through study completion, an average of 1 or 1,5 years

• Efficacy endpoint 2: mean Change in Fasting Glucose

  Through study completion, an average of 1 or 1,5 years

• Efficacy endpoint 2: mean Change in Time in Range (TIR)

  Through study completion, an average of 1 or 1,5 years

• Efficacy endpoint 3: In patients with baseline abnormal Alanine Transaminase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) values, change in ALT, AST, GGT

  Through study completion, an average of 1 or 1,5 years

Study Arms (2)

DMR procedure

ACTIVE COMPARATOR

Patients receive Revita® DMR Treatment Paradigm 1. After unblinding at 24 weeks, they receive retreatment.

Device: Revita® DMR Treatment

Sham procedure

SHAM COMPARATOR

Patients receive a sham procedure. After unblinding takes place at 24 weeks, patients receive a Revita® DMR Treatment Paradigm 1. 48 weeks after initial sham (= 24 weeks after first DMR) patients may receive retreatment, if they want to.

Other: Sham procedure

Interventions

Revita® DMR Treatment DEVICE

The Revita® System is an endoscopic treatment consisting of a single catheter and console designed to lift the duodenal mucosa with saline followed by controlled circumferential hydrothermal ablation of the mucosa. For this study Revita® DMR procedure will be conducted as follows: DMR Treatment Paradigm 1- After initial 2 Lift and Ablate step, remaining Lift: Ablate steps will be conducted in 1:1 manner.

Also known as: Revita® DMR Treatment Paradigm 1, Revita Duodenal Mucosal Resurfacing

DMR procedure

Sham procedure OTHER

The sham control for the Revita DMR procedure.

Sham procedure

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with Type 2 Diabetes.
• Age ≥ 18 to ≤ 75 years.
• Insulin naïve patients who are on stable dose (maximally approved or tolerated dose) of 2 or more glucose lowering drugs, including metformin, sulphonylurea (SU), (sodium-glucose cotransporter-2) inhibitors (SGLT-2i), Glucagon-like peptide-1 receptor agonists (GLP-1RA) or dipeptidyl peptidase 4 inhibitor (DPP-4i) and/or, thiazolidinedionderivaten (TZD) for at least 12 weeks.
• BMI ≥ 24 and ≤ 40 kg/m2
• HbA1c of ≥ 54 mmol/mol (7.5%) and ≤ 86 mmol/mol (10.0%).
• Signed and dated written informed consent in accordance with Good Clinical Practice (GCP) and local legislation.

You may not qualify if:

• Uncontrolled hyperglycemia with a glucose level \>270 mg/dl (\>15.0 mmol/L) after an overnight 8-hour fasting at the end of run-in and confirmed by a second measurement on the consecutive day.
• Subjects who are using insuline.
• Known case of absolute insulin deficiency as indicated by a fasting plasma C-peptide value of \<0.6 ng/ml (\<0,2 nmol/L).
• Diagnosis of autoimmune diabetes/Type 1 diabetes mellitus, monogenic (neonatal or maturity onset diabetes of the young (MODY)) diabetes or Type 1 diabetes in adults/latent autoimmune diabetes of adults (LADA).
• History of more than 1 severe hypoglycemia episode or unawareness within past 6 months in which third party assistance was needed.
• Clinically significant valvular heart disease or severe aortic stenosis.
• Acute coronary syndrome (non-ST wave elevated myocardial infarction (STEMI), STEMI and unstable angina pectoris), stroke or transient ischemic attack within the past 3 months.
• Indication of acute liver disease, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN).
• Presence of acute or chronic active hepatitis B or C (except if hepatitis C is cured) or cirrhosis; or hepatic decompensation during the last 6 months; or alcoholic or autoimmune chronic hepatitis.
• Impaired renal function, defined as estimated Glomerular Filtration rate (eGFR) \< 45 ml/min/1.73m2 or end stage renal failure or on dialysis.
• Diagnosed with esophageal motility disorder or Glomerular Filtration rate (GERD) gr 3 or diagnosed during screening endoscopy.
• Known history of a structural or functional disorder of the stomach, e.g. active gastric ulcer, chronic gastritis, gastric varices, hiatal hernia, stomach cancer or any other disorder of the stomach.
• Previous GI surgery that could affect the ability to treat the duodenum such as patients who have had a Billroth 2, Roux-and-Y gastric bypass, gastric sleeve or other similar procedures.
• Known intestinal autoimmune disease, including Celiac disease, or pre-existing symptoms of lupus erythematosus, scleroderma, or other autoimmune connective tissue disorder, which affects the small intestine.
• Patients with active helicobacter pylori infection. Patients may be enrolled if they had history of h-pylori infection and were successfully treated.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Fractyl Health Inc.: collaborator

Study Sites (1)

Amsterdam UMC, locatie VUmc

Amsterdam, Netherlands

RECRUITING

Related Links

• Website for people that are interested in participating.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jacques JG Bergman, MD, PhD

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kim van den Hoek, MD

CONTACT

+31621357593; k.vandenhoek@amsterdamumc.nl

Celine BE Busch, MD

CONTACT

+31621357593; c.b.busch@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In this study, both the study team and the study subjects are blinded to the treatment through the 24 week follow-up visit. While the endoscopist is not blinded to individual treatments, he is blinded to cohort level data and is not responsible for patient follow-up. At the 24 week visit, the subject and study team are unblinded. The subjects who received the sham treatment undergo DMR treatment.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Model Details: The study is a single-center, randomized, double-blind, sham-controlled trial

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: October 23, 2023
• Study Start: August 9, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)