Study to Evaluate the Efficacy and Safety of Duodenal Mucosal Resurfacing Using the Revita System in Patients with Type 2 Diabetes on Insulin therapy

Brief description of study

The purpose of this research study is to learn more about the use of the Fractyl Revita® System for the treatment of type 2 diabetes for patients who are on insulin therapy.

Researchers believe that the first layer (the mucosa, which is the closest layer to the intestinal cavity and in touch with any food that is ingested) of the duodenum (the part of the small intestine immediately after the stomach) has an important role in the control of type 2 diabetes. This layer (mucosa) is responsible for the absorption of nutrients and it is believed to be in excess in patients with type 2 Diabetes. By removing this excess layer of the duodenum, the procedure may help to improve blood sugar control, insulin resistance (the ability of cells to respond to insulin), and overall metabolic control (processes that maintain energy expenditure). Modifying the function of this layer of the small intestine may improve the control of your diabetes. The first layer (mucosa) of the duodenum will be heated using the Fractyl Revita® System. This will initiate a healing process to create a new mucosal layer, thereby modifying the function. This heating and healing process is called duodenal mucosal resurfacing (DMR).

The study device, the Revita® System, has not been approved for use by the Food and Drug Administration (FDA) in the United States - it is an experimental treatment. The Revita® System is commercially available in the United Kingdom and is CE marked in Europe.

The DMR procedure using the study device will be compared to a Sham procedure. The Sham procedure is similar to the DMR procedure, but leaves out the heating, which is the key therapeutic element of the DMR procedure.

Clinical Study Identifier: s21-00760 Identifier: NCT04419779
Principal Investigator: Roshney Jacob-Issac.
Other Investigator: Seth A. Gross.

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