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

NCT ID: NCT06256497

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: SUSPENDED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-27
• Study Completion Date: 2028-12-01

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

DMR Treated Patients

Duodenal Mucosal Resurfacing (DMR)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Revita DMR

Eligibility Criteria

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

-

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

Sponsors

Fractyl Health Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephan Martin, MD

Role: PRINCIPAL_INVESTIGATOR

Head of Diabetology and Director of the West-German Diabetology and Health Center (WDGZ)

Jochen Seufert, MD

Role: STUDY_CHAIR

Department Head Endocrinology and Diabetology, University Hospital Freiburg

Locations

Westdeutsches Diabetes und Gesundheitszentrum

Düsseldorf, , Germany

Countries

Germany

Other Identifiers

C-00075

Identifier Type: -

Identifier Source: org_study_id