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Clinical trial

First patients enrolled in Revita-1 DMR clinical trial

Trial will evaluate implant-free duodenal mucosal resurfacing for type 2 diabetes

Fractyl Laboratories has announced that enrolment has begun in a multicenter clinical trial (Revita-1 trial) being conducted in Europe and South America to evaluate the safety and performance of the Revita Duodenal Mucosal Resurfacing (DMR) System.  Revita is the first non-invasive, implant free duodenal resurfacing procedural therapy designed to directly treat the digestive causes of insulin resistance in patients with uncontrolled type 2 diabetes.

“The Revita-1 study will expand our understanding of the safety and efficacy of the Revita DMR procedure in patients with type 2 diabetes,” said Dr Harith Rajagopalan, Co-Founder and CEO of Fractyl. “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.”

More than ten patients have been treated in the first phase of the Revita-1 study, which will enroll 50 patients across ten international sites. The primary efficacy endpoint is change in HbA1c in patients with uncontrolled type 2 diabetes, defined as having poor glucose control on oral medications and an HbA1c of 7.5 to 10 percent.  The second phase of the study, a double-blinded, sham-controlled trial that will enroll up to 240 patients, will begin in 2016.

The Revita device allows physicians to easily separate the mucosal layer of the duodenum from the sub-muscosa

“My center has now treated four patients in the Revita 1 trial, and two patients have crossed the one-month threshold and appear to be well satisfied with this minimally invasive procedure,” said Dr Geltrude Mingrone. “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.”

After the mucosal layer is separated, the ablation balloon catheter is delivered into the duodenum

Revita DMR is a minimally-invasive procedure designed to safely alter the inner surface of the duodenum and change how the body absorbs and processes sugar. The procedure is an endoscopic procedure that thermal ablates the duodenal mucosa.  The company claims procedure has the potential to delay the need for insulin therapy and free patients from the burdens associated with managing type 2 diabetes, particularly when oral medications have failed.

The company has previously announced the results from the company’s proof-of-principal study, demonstrate the safety and effectiveness of the Revita procedure at the IFSO World Congress in Montreal (August 2014).

This study included 30 patients (22 male; mean age, 53.7 ± 8.2 years; mean BMI, 31.3 ± 3.5) with uncontrolled diabetes (mean HbA1c, 9.2%; mean diabetes duration, 5.7 ± 3 years) and HbA1c levels averaging 9.2 prior to treatment.In the 19 patients who received DMR over several cms of their duodenum, HbA1c levels dropped to 7.1, on average, after three months and remained stable six months after the procedure. The treatment effect appears to be dose-dependent, as those patients who received DMR over a shorter segment of their duodenum did not experience as significant of a benefit.

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