Fractyl Laboratories inc REVITA-2 Study C-30000
Research type
Research Study
Full title
Evaluation of the effect of Duodenal Mucosal Resurfacing (DMR) using the Revita System in the treatment of Type 2 diabetes (T2D); REVITA-2 Study
IRAS ID
209250
Contact name
Rehan Haidry
Contact email
Sponsor organisation
Fractyl Laboratories inc.
Duration of Study in the UK
2 years, 9 months, 30 days
Research summary
The study is a post market study with the "Fractyl Revita System" which is a gastro-endoscopic procedure for the treatment of diabetes Type 2. The way to achieve improvement of the control of the blood sugar with these patients is by ablation of the duodenal mucosa and initiate a renewal of the mucosa and as such initiate an enhancement on the metabolistic response to control the blood sugar levels.
In order to further investigate the efficacy of the treatment, this double blind randomized SHAM study is setup to determine the function of the blood sugar control trough a so called mixed meal tolerance test (MMTT) during which the Glucose, pancreatic and gut hormones and Metabolic substrate screen are tested.
Patient eligible for the study should be between 28-75 years, 2, diagnosed with Type 2 Diabetes and evidence of preserved insulin secretion. On a minimum of 2 stable oral anti-diabetic medications with no changes in medication in the previous 12 Weeks prior to study entry.
The study is a multi center study in the EU and will be conducted at 2-3 NHS sites in England. It involves an endoscopic treatment and an endocrinologist evaluation pre- and post treatment.
The study duration is 24 weeks post treatment where the patient and study team are unblinded. At this time point the SHAM patients can choose to undergo an active treatment. All patients are followed up to 48 weeks.REC name
London - Dulwich Research Ethics Committee
REC reference
16/LO/1755
Date of REC Opinion
15 Nov 2016
REC opinion
Further Information Favourable Opinion