Fractyl Labs said today it enrolled the 1st patients in a trial of its Revita duodenal mucosal resurfacing system designed to treat the digestive causes of insulin resistance in patients with type 2 diabetes.
The Revita device is designed to ablate the duodenum (the first part of the intestine) in order to alter glucose metabolism. Fractyl calls its approach the “first procedural therapy to treat type 2 diabetes.”
More than 10 patients have been enrolled and treated in the 1st phase of the Revita-1 study, which is slated to enroll 50 patients across 10 sites. The study seeks to explore changes in HbA1c in patients with diabetes who have poor glucose control on oral medications, Waltham, Mass.-based Fractyl said.
“My center has now treated 4 patients in the Revita 1 trial, and 2 patients have crossed the 1-month threshold and appear to be well satisfied with this minimally invasive procedure. We have known for some time that bariatric surgeries can improve glycemic control independent of weight loss; it will be interesting to see if Revita can offer a safe, less invasive option with similar metabolic benefits,” Dr. Geltrude Mingrone said in a press release.
The 2nd phase of the study will be a 240-patient double-blinded, sham-controlled trial set to begin enrollment in 2016.
“The Revita-1 study will expand our understanding of the safety and efficacy of the Revita DMR procedure in patients with type 2 diabetes. It will also guide our plans for multi-arm pivotal trials, along with data from our earlier, proof-of-concept human studies that we plan to publish this year,” CEO Dr. Harith Rajagopalan said in prepared remarks.
Registration is open for DeviceTalks Boston! Join us on June 5-6, 2019, as we explore the trends and technology that are shaping the future of the medical device industry.