Clinical Trials
If there was the possibility you could GAIN CONTROL of your TYPE 2 DIABETES and WEIGHT, would you do it?
The STEP-1 Trial may be the answer.
The STEP-1 Trial is a United States (US) clinical study of the medical device known as EndoBarrier®.
The STEP-1 Trial is a United States (US) clinical study of the medical device known as EndoBarrier®. EndoBarrier is intended for patients who do not have adequate control of their type 2 diabetes and obesity through their current medication and lifestyle.
What is EndoBarrier?
EndoBarrier is a minimally-invasive medical device that is endoscopically implanted temporarily in the small intestine directly below the stomach. It has been shown to reduce HbA1c, BMI, weight, and other health-related metrics through previous clinical studies that were preformed outside of the US.
For a medical device to become commercially available in the US, it must go through extensive clinical research to support that it is safe and effective to the Food and Drug Administration (FDA) via clinical trial data.
The STEP-1 Trial is currently enrolling patients at 5 clinical study sites.
Are you a candidate for the STEP-1 Trial?
You may be a candidate if these apply to you:
- HbA1c: 8 – 10%
- BMI: 30 – 50 kg/m2
- Age: 30 – 65
- Not currently taking insulin
- Have been diagnosed with type 2 diabetes less than 15 years
STEP-1 Trial Site Locations
Brigham & Women’s Hospital – Boston, Massachusetts
- University of Miami Hospital – Miami, FL
- Michigan Medicine Ann Arbor, Michigan
- Baylor College of Medicine Houston, Texas
- Thomas Jefferson University Hospital Philadelphia, Pennsylvania
- MedStar Health – Washington D.C. & Olney, MD
Interested in joining the STEP-1 Trial?
GI Dynamics is currently enrolling patients for Stage 1 of its STEP-1 Trial of EndoBarrier in the US. If you or someone you know are interested in participating in the study and would like to see if you qualify to join, learn more here.
Frequently Asked Questions
1. Why should I participate in this study?
Participants in the STEP-1 trial may obtain significant health benefits, as well as aid in the possibility of bringing a much-needed medical device to the Unites States market for other people unable to control their type 2 diabetes with the current care they are receiving.
2. How long while I be in the study?
The study duration is 24 months.
3. What are the requirements of the study?
During the study you will be required make regular visits to the study doctors, and to measure your blood sugars, temperature and weight daily. Your study doctor will order blood tests, liver scans and other tests regularly throughout the trial. Additionally, you will receive lifestyle guidance regularly from a registered dietician.
4. Will it cost me anything to be in the study?
No.
5. Will I be compensated to be in the study?
Participants are not paid to be part of the study but will be receiving, at no charge, regular medical care and lifestyle counselling throughout the study. Participants will receive compensation for travel expenses.
