• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • Clinical Trial Listings
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Market Research
    • Benchmark Reports
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
  • White Papers
  • Clinical Trial Listings
  • Advertise
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » First patients enrolled in multicenter trial of Fractyl Revita DMR System

First patients enrolled in multicenter trial of Fractyl Revita DMR System

July 17, 2015
CenterWatch Staff

Fractyl Laboratories, a private company based in Waltham, Mass., has begun patient enrollment in a multicenter clinical trial (Revita-1) 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 Harith Rajagopalan, M.D., Ph.D., co-founder and CEO of Fractyl. “It also will 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 10 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%. The second phase of the study, a double-blinded, sham-controlled trial that will enroll up to 240 patients, will begin in 2016.

“My center now has 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 Geltrude Mingrone, M.D., Ph.D. “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.”

    Upcoming Events

    • 16Oct

      MAGI@home Clinical Research Conference 2023

    • 25Oct

      2023 WCG Patient Forum

    • 26Oct

      FDA in 2024: What to Expect in an Election Year

    Featured Products

    • Surviving an FDA GCP Inspection

      Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

    • Best Practices for Clinical Trial Site Management

      Best Practices for Clinical Trial Site Management

    Featured Stories

    • Donna Snyder

      New WCG Executive Physician Outlines Goals for Clinical Research

    • Hand Shake at Meeting

      Partnership to Bolster Trials in Low Resource Regions Kicks Off

    • Guidelines-360x240.png

      Major Industry Groups Offer Feedback on ICH’s E6(R3) Guidelines

    • AsktheExpertsBadge-360x240.png

      Ask the Experts: Monitoring

    Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

    The information you need to adapt your monitoring plan to changing times.

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy
    • Do Not Sell or Share My Data

    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 703.538.7600 – Toll free 888.838.5578

    Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing