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

March 12, 2025 updated by: Fractyl Health Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical effectiveness
Time Frame: Baseline, 1, 3-, 6-, 12-, and 24-months post-procedure.
Improvement in glycemic control measured by fasting blood glucose (FPG)
Baseline, 1, 3-, 6-, 12-, and 24-months post-procedure.
Clinical effectiveness
Time Frame: Baseline, 1, 3-, 6-, 12-, and 24-months post-procedure.
Improvement in glycemic control measured by HbA1c, random glucose (non-fasting),
Baseline, 1, 3-, 6-, 12-, and 24-months post-procedure.
Clinical effectiveness
Time Frame: Baseline, 1, 3-, 6-, 12-, and 24-months post-procedure.
Improvement in glycemic control measured by fasting insulin
Baseline, 1, 3-, 6-, 12-, and 24-months post-procedure.
Clinical effectiveness
Time Frame: Baseline, 1, 3-, 6-, 12-, and 24-months post-procedure.
Improvement in glycemic control measured by fasting plasma glucagon
Baseline, 1, 3-, 6-, 12-, and 24-months post-procedure.
Clinical effectiveness
Time Frame: Baseline, 1, 3-, 6-, 12-, and 24-months post-procedure.
Improvement in glycemic control measured by C-peptide.
Baseline, 1, 3-, 6-, 12-, and 24-months post-procedure.
Clinical effectiveness
Time Frame: Baseline, 1, 3-, 6-, 12-, and 24-months post-procedure.
Changes in antidiabetic medication dosages
Baseline, 1, 3-, 6-, 12-, and 24-months post-procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fractyl Health Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 27, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 13, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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