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C-4000 Randomized, Double-Blind, Sham-Controlled, Prospective, Multi-Center Pilot Study To Evaluate The Safety And Effectiveness Of Duodenal Mucosal Resurfacing Using The Revita System In The Treatment Of Type 2 Diabetes

NCT03653091

Randomized, Double-Blind, Sham-Controlled, Prospective, Multi-Center Pilot Study To Evaluate The Safety And Effectiveness Of Duodenal Mucosal Resurfacing Using The Revita System In The Treatment Of Type 2 Diabetes

Principal Investigator

Sponsor

Fractyl Laboratories

This study is being run for research purposes. The study device, the Fractyl Revita System, is being tested for the treatment of Type 2 diabetes. The purpose of this study is to learn more about the use of the Revita System for the treatment of Type 2 diabetes.
The innermost layer (mucosa) of the duodenum (the part of the small intestine immediately after the stomach) has an important role in the control of Type 2 diabetes. Modifying the function of this layer of the small intestine may improve the control of your diabetes. The innermost 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. 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 in the United States - it is experimental. The DMR procedure using the study device will be compared to a sham procedure. The sham procedure is similar to the real procedure, but leaves out the heating, which is the key therapeutic element of the real procedure. In this study, you will either be treated with the real DMR procedure (using the Revita System) or the sham procedure. Whether you are treated with the real or sham procedure will be decided randomly (by chance, like drawing straws). In this study, 1 out of every 3 participants (33%) will receive sham. To make the study fair, you and the study doctor will not be told which treatment you are receiving. This is called 'blinding'. Six months after your procedure, you will be told which procedure you received. If you received the sham, you will be offered the opportunity to receive treatment with the real DMR procedure.