Diabetes Mellitus, Type 2
Conditions
Keywords
Type 2 Diabetes, DMR, Duodenal Mucosal Resurfacing, Revita
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.
Interventions
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.
Sponsors
Fractyl Health Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical effectiveness | Baseline, 1, 3-, 6-, 12-, and 24-months post-procedure. | Improvement in glycemic control measured by fasting blood glucose (FPG) |
Countries
Germany
Outcome results
None listed