RevitaT2Di Pivotal Study (REVITALIZE 1)

RevitaT2Di Pivotal Study (REVITALIZE 1)

RevitaT2Di Pivotal Study (REVITALIZE 1)
Recruiting
21 years - 70 years
All
Phase N/A
20 participants needed
1 Location

Brief description of study

The Revitalize-1 Study will look at a potential procedure called duodenal mucosal resurfacing (DMR). The DMR procedure acts on the first layer (mucosa) of the duodenum (the part of the small intestine located immediately after the stomach). By removing an excess layer, the treatment may improve blood sugar control. This treatment may eliminate or reduce the need for insulin injections in the future for the treatment of Type 2 Diabetes.

Detailed description of study

Study participation will last for a total of 48-96 weeks. You will be compensated for participation in this study, and will not have to pay for any study procedures. In addition to receiving either the Revita™ DMR procedure or control procedure, you will diabetes medication counseling and will undergo the following medical procedures: routine blood work, EKG, MRI, fibroscan, and endoscopy.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Type 2 Diabetes
  • Age: 21 years - 70 years
  • Gender: All

You may be eligible for this study if:

1. You have Type 2 Diabetes
2. You are using insulin and take metformin to manage your diabetes
4. Your A1c is between 7.5% and 9.5%
5. Your BMI is between 24 and 40

This study investigates a procedure called duodenal mucosal resurfacing (DMR) for individuals with Type 2 Diabetes. The DMR procedure targets the mucosa, the first layer of the duodenum, which is part of the small intestine located immediately after the stomach.

The study evaluates whether the DMR procedure can improve blood sugar control and potentially reduce or eliminate the need for insulin injections in the future.

  • Who can participate: Adults with Type 2 Diabetes who are using insulin and taking metformin may be eligible. Participants should have an A1c between 7.5% and 9.5% and a BMI between 24 and 40.
  • Study details: Participants will undergo the DMR procedure or a control procedure, along with diabetes medication counseling. They will also have routine blood work, EKG, MRI, fibroscan, and endoscopy.
  • Study timelines: The study will last 48-96 weeks.
Updated on 04 Aug 2024. Study ID: 849853

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