A Prospective Study to Evaluate Revita DMR Post Market Pilot Clinical Follow-Up Registry in Patient with Type 2 Diabetes

Revita DMR Post Market Pilot Clinical Registry

The Revita DMR Post Market Pilot Clinical Registry is a post-market, prospective, observational, noninterventional clinical registry in patients with T2D in Germany undergoing the Revita Procedure with the CE marked Revita System (Fractyl Health, Lexington, MA, USA) in accordance with its intended purposes. Patient's participation in this study has no impact on his or her indication or opportunity to receive therapy. Patients are to be treated in compliance with the current Revita System's IFU of the CE marked Revita System as well as according to medical society guidelines and physician discretion.

Study Overview

• Status: Suspended
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Device: Duodenal Mucosal Resurfacing (DMR)

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• Germany
  • Duesseldorf, Germany, 40591
    • Westdeutsches Diabetes und Gesundheitszentrum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with T2D in Germany undergoing the Revita Procedure with the CE marked Revita System (Fractyl Health, Lexington, MA, USA) in accordance with its intended purposes and meeting the study inclusion and exclusion criteria below. Patient's participation in this study has no impact on his or her indication or opportunity to receive therapy. Patients are to be treated in compliance with the current Revita System's IFU of the CE marked Revita System as well as according to medical society guidelines and physician discretion.

Description

Inclusion Criteria:

• Signed and dated informed consent in accordance with GCP and local legislation
• Adults (≥18 years) with the diagnosis of T2D
• BMI of <=45 kg/m2 at the time of presentation/screening
• T2D mellitus inadequately controlled on therapy (HbA1c ≥7.0 and ≤10.0% [53-86 mmol/mol] at the time of initial presentation for screening and with the need for therapy escalation [dose increase of existing therapy or additional prescription of insulin and/or OADs or change of therapy regimen]) to achieve the therapeutic HbA1c target defined by the physician
• Treatment with oral and/or injectable glucose lowering medications and/or long-acting insulin therapy

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

DMR Treated Patients

Device: Duodenal Mucosal Resurfacing (DMR); The Revita System is a hydrothermal ablation system, (CE) certified, intended to impart insulin-sensitizing properties to the body via ablation & rejuvenation of the duodenal mucosa. As an adjunct to diet and exercise, Revita is intended to 1. improve glycemic control in patients with T2D who have preserved pancreatic beta cell function and whose diabetes is inadequately controlled despite oral and/or injectable glucose lowering medications and/or long-acting insulin therapy, 2. Reduce liver fat in patients with T2D and Non-Alcoholic Fatty Liver Disease (NAFLD). The single use Revita Catheter and Line Set are provided sterile and are not implantable or reusable. These disposables are used with the Revita Console an electromechanical device that controls the ablation cycle and submucosal expansion. The Revita System is used in a suitably equipped endoscopy suite. The Catheter contacts the patient's digestive tract for approximately 45-60 minutes.; Other Names: Revita DMR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical effectiveness	Improvement in glycemic control measured by fasting blood glucose (FPG)	Baseline, 1, 3-, 6-, 12-, and 24-months post-procedure.
Clinical effectiveness	Improvement in glycemic control measured by HbA1c, random glucose (non-fasting),	Baseline, 1, 3-, 6-, 12-, and 24-months post-procedure.
Clinical effectiveness	Improvement in glycemic control measured by fasting insulin	Baseline, 1, 3-, 6-, 12-, and 24-months post-procedure.
Clinical effectiveness	Improvement in glycemic control measured by fasting plasma glucagon	Baseline, 1, 3-, 6-, 12-, and 24-months post-procedure.
Clinical effectiveness	Improvement in glycemic control measured by C-peptide.	Baseline, 1, 3-, 6-, 12-, and 24-months post-procedure.
Clinical effectiveness	Changes in antidiabetic medication dosages	Baseline, 1, 3-, 6-, 12-, and 24-months post-procedure.

Collaborators and Investigators

• Sponsor: Fractyl Health Inc.
• Investigators: Principal Investigator: Stephan Martin, MD, Head of Diabetology and Director of the West-German Diabetology and Health Center (WDGZ); Study Chair: Jochen Seufert, MD, Department Head Endocrinology and Diabetology, University Hospital Freiburg

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2023
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: February 5, 2024
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Actual): February 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Type 2 Diabetes; Duodenal Mucosal Resurfacing; DMR; Revita
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: C-00075

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes