REVITALIZE-1: A Prospective randomized, double-blind, sham-controlled, multi-center pivotal study to evaluate the efficacy and safety of Duodenal Mucosal Resurfacing (DMR) using the Revita system in subjects with type 2 diabetes on insulin therapy.

Study Purpose: The purpose of this study is to demonstrate the efficacy and safety of the Fractyl DMR Procedure using the Revita System compared to a sham.

To be enrolled in this study, you must meet certain requirements. You may be eligible to participate if you meet the following criteria:

Study Duration: One (1) year with the possibility of up to two (2) years if subject is in the sham group.

Study Commitment: 3 Visits to confirm eligibility, 7 Outpatient visits, 5 Phone calls

Age: 21-70 years old

Sex: Male and Female

Conditions/Eligibility: Subjects with type 2 diabetes on stable doses of 20-100 units (both inclusive) of total daily insulin dose of basal insulin or basal insulin combined with short-acting insulin and up to 3 permitted non-insulin antidiabetic agents (ADAs).

Study Procedures: Physical exam, vital signs, height, weight, BMI, screening labs, urine screen, measurement of waist and hip circumference, EKG -Endoscopy (followed by Randomization if all eligibility is met and -Duodenal Mucosal Resurfacing or Sham procedure) -Urine screen and pregnancy test for women of childbearing potential

Compensation: You can receive up to $1,450.

Please call
Call407-303-7193 or fill out the Contact Form below for more information.