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

Fractyl Health

Status: Suspended

Conditions: Diabetes Mellitus, Type 2

Treatments: Device: Duodenal Mucosal Resurfacing (DMR)

Study type: Observational

Funder types: Industry

Identifiers

NCT06256497

C-00075

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

DMR Treated Patients

Treatment:

Device: Duodenal Mucosal Resurfacing (DMR)