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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Revita DMR Post Market Pilot Clinical Registry

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06256497
• Other study ID #: C-00075
• Status: Enrolling by invitation
• Start date: June 27, 2023
• Est. completion date: December 1, 2028

Study information

• Verified date: February 2024
• Source: Fractyl Health Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 1, 2028
• Est. primary completion date: July 1, 2028
• Gender: All
• Age group: 18 Years and older

Eligibility

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: -

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

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.

Locations

Country	Name	City	State
Germany	Westdeutsches Diabetes und Gesundheitszentrum	Duesseldorf

Sponsors (1)

Lead Sponsor	Collaborator
Fractyl Health Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical effectiveness	Improvement in glycemic control measured by fasting blood glucose (FPG), HbA1c, random glucose (non-fasting), fasting insulin, fasting plasma glucagon, C-peptide.	Baseline, 1, 3-, 6-, 12-, and 24-months post-procedure.