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

NCT06256497 | Suspended DMC FDA Device

• 1 other identifier: C-00075
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Type 2 Diabetes; DMR; Duodenal Mucosal Resurfacing; Revita

Outcome Measures

Primary Outcomes (6)

• 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.

Study Arms (1)

DMR Treated Patients

Device: Duodenal Mucosal Resurfacing (DMR)

Interventions

Duodenal Mucosal Resurfacing (DMR) 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.

Also known as: Revita DMR

DMR Treated Patients

Eligibility Criteria

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

You may qualify if:

• 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

Sponsors & Collaborators

• Fractyl Health Inc.: lead

Study Sites (1)

Westdeutsches Diabetes und Gesundheitszentrum

Düsseldorf, 40591, Germany

Location

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

• Stephan Martin, MD

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

  PRINCIPAL INVESTIGATOR

• Jochen Seufert, MD

  Department Head Endocrinology and Diabetology, University Hospital Freiburg

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 13, 2024
• Study Start: June 27, 2023
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)