A Multicenter, Double-blind, Sham-controlled Study for Assessing the Safety and Effectiveness of Endoscopic Intestinal Re-Cellularization Therapy in Individuals with Type 2 Diabetes

Study Purpose: To study changes in blood glucose control and weight loss in Type II Diabetics using Nutrition and Lifestyle Counseling combined with an investigational device called the ReCET Intestinal Cellular Regeneration System

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: ~15 months

Study Commitment:
1 Screening Visit
1 Baseline Visit
1 Procedure Visit
17 Follow Up Visits
Phone Calls

Age: 22-70 years old

Sex: Male & Female

Conditions/Eligibility:

T2D, at least 6 months
Treated with diabetes medications but have not achieved an optimal blood sugar level
BMI 27-40 kg/m2
No major GI disorders/diseases
Generally healthy, additional safety screening criteria upon first visits

Study Procedures:
Nutrition & Lifestyle Counseling
ReCET Procedure
Medical History review, Physical exams
Vital Signs
Bloodwork, Pregnancy testing
Weight, Height, Waist measurements
Blood glucose monitoring sensors (CGM) & diaries
Questionnaires

Compensation: up to $4000