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

NCT ID: NCT06092476

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-09
• Study Completion Date: 2027-07-01

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.

Detailed Description

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.

The aimed effect is an adequate or improved glucose regulation and a decrease of HbA1c. Secondary effects include improved cardiovascular, hepatic, and metabolic parameters.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

DMR procedure

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

Group Type: ACTIVE_COMPARATOR

Revita® DMR Treatment

Intervention Type: 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.

Sham procedure

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.

Group Type: SHAM_COMPARATOR

Sham procedure

Intervention Type: OTHER

The sham control for the Revita DMR procedure.

Interventions

Revita® DMR Treatment

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.

Intervention Type: DEVICE

Sham procedure

The sham control for the Revita DMR procedure.

Intervention Type: OTHER

Other Intervention Names

Revita® DMR Treatment Paradigm 1; Revita Duodenal Mucosal Resurfacing

Eligibility Criteria

Inclusion Criteria

1. Diagnosed with Type 2 Diabetes.

2. Age ≥ 18 to ≤ 75 years.

3. 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.

4. BMI ≥ 24 and ≤ 40 kg/m2

5. HbA1c of ≥ 54 mmol/mol (7.5%) and ≤ 86 mmol/mol (10.0%).

6. Signed and dated written informed consent in accordance with Good Clinical Practice (GCP) and local legislation.

Exclusion Criteria

1. 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.

2. Subjects who are using insuline.

3. Known case of absolute insulin deficiency as indicated by a fasting plasma C-peptide value of <0.6 ng/ml (<0,2 nmol/L).

4. 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).

5. History of more than 1 severe hypoglycemia episode or unawareness within past 6 months in which third party assistance was needed.

6. Clinically significant valvular heart disease or severe aortic stenosis.

7. 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.

8. 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).

9. 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.

10. Impaired renal function, defined as estimated Glomerular Filtration rate (eGFR) < 45 ml/min/1.73m2 or end stage renal failure or on dialysis.

11. Diagnosed with esophageal motility disorder or Glomerular Filtration rate (GERD) gr 3 or diagnosed during screening endoscopy.

12. 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.

13. 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.

14. 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.

15. Patients with active helicobacter pylori infection. Patients may be enrolled if they had history of h-pylori infection and were successfully treated.

16. History of active malignancy or partial remission from clinically significant malignancy within the past 5 years. With the exception of basal or squamous cell skin cancer or carcinoma in situ or those received curative treatment and in complete remission for 5 years or if subject confirmed as cancer free.

17. Blood dyscrasias or any disorders causing hemolysis or unstable Red Blood Cells (sickle cell trait is allowed).

18. Known case of severe peripheral vascular disease.

19. Clinically active systemic infection.

20. Known immunocompromised status, including individuals who have undergone organ transplantation, chemotherapy, or radiotherapy within the past 12 months, clinically significant leukopenia or positive for the human immunodeficiency virus (HIV), on potential immunosuppressants.

21. Current treatment with systemic steroids or change in dosage of thyroid hormones within 6 weeks prior to consent or any other uncontrolled endocrine disorder.

22. Use of anticoagulation therapy (such as warfarin, coumadin, Novel Oral AntiCoagulants (NOAC) or anti-platelet agents (such as thienopyridine) which cannot be discontinued for 5-7 days or 2 drug half-lives before the procedure; Acetylsalicylic acid does not need to be discontinued.

23. Actively participating in weight loss program or using medications for weight loss 3 months prior to randomization.

24. General contraindications to deep or conscious sedation or general anesthesia or high risk (e.g., American Society of Anesthesiologists Classification (ASA) 4 or higher) or contraindications to upper GI Endoscopy.

25. Nursing or Pregnant women or women of child bearing potential who are unwilling to practice acceptable method of birth control.

26. History of alcohol, legal or illegal drug and substance abuse.

27. Intake of an investigational drug in another trial within 30 days prior to consent or active participation in another clinical trial of an investigational drug or device.

28. Any other clinical or mental condition which would jeopardize subject's safety or makes subject a poor candidate for clinical trial participation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fractyl Health Inc.

INDUSTRY

Sponsor Role: collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role: lead

Responsible Party

Jacques J.G.H.M. Bergman

Prof. dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jacques JG Bergman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC

Locations

Amsterdam UMC, locatie VUmc

Amsterdam, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Kim van den Hoek, MD

Role: CONTACT

k.vandenhoek@amsterdamumc.nl

+31621357593

Celine BE Busch, MD

Role: CONTACT

c.b.busch@amsterdamumc.nl

+31621357593

Facility Contacts

Kim van den Hoek, MD

Role: primary

k.vandenhoek@amsterdamumc.nl

0031621357593

Related Links

https://onderzoekdiabetes.nl/

Website for people that are interested in participating.

Other Identifiers

NL82963.018.23

Identifier Type: -

Identifier Source: org_study_id