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

Suspended

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Device: Duodenal Mucosal Resurfacing (DMR)

• Registration Number: NCT06256497
• Lead Sponsor: Fractyl Health Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-27
• Study First Submitted: 2024-02-05
• Study First Submitted QC: 2024-02-05
• Study First Posted: 2024-02-13
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-14
• Primary Completion: 2028-07-01
• Study Completion: 2028-12-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DMR Treated Patients	Duodenal Mucosal Resurfacing (DMR)	-

Primary Outcome Measures

Name	Time	Method
Clinical effectiveness	Baseline, 1, 3-, 6-, 12-, and 24-months post-procedure.	Changes in antidiabetic medication dosages

Trial Locations

Locations (1)

Westdeutsches Diabetes und Gesundheitszentrum; 🇩🇪 Duesseldorf, Germany