1. What is the purpose of a clinical trial?

Clinical trials are research studies designed to find out about the safety and effectiveness of possible new medications, medical devices, and medical procedures. Although there are many types of clinical trials, all must conform to strict rules set by the U.S. Food and Drug Administration (FDA). These rules help protect the rights and safety of those who volunteer to take part in clinical trials.

2. What is EndoBarrier^®?

EndoBarrier is an investigational, non-surgical medical device designed to decrease blood sugar and body weight. EndoBarrier is a thin, flexible, tube-shaped liner that forms a physical barrier between the food you eat and a portion of the intestinal wall. It is designed to change the way the body responds to food, by altering the release of natural chemicals called hormones. This may help reduce appetite and improve the body’s ability to control blood sugar.

EndoBarrier has been studied in 13 clinical trials and used in over 1,000 people outside of the U.S. It is only available in the United States through the ENDO Trial.

3. How is EndoBarrier placed?

EndoBarrier is placed without incisions using a thin flexible tube called an endoscope. To place EndoBarrier, the endoscope is passed through the mouth and into the stomach. The EndoBarrier device is then precisely placed at the beginning of the small intestine. The EndoBarrier procedure is reversible and does not alter the body’s natural anatomy. EndoBarrier is designed to stay in place for up to one year to help you manage your blood sugar and body weight, and is then removed without incisions using an endoscope.

4. Are there any costs involved in the ENDO Trial?

If you qualify and choose to join the ENDO Trial, you will receive study-related care at no cost. This includes the EndoBarrier device, as well as any examinations or follow-up visits required for the study. You may also be compensated for any travel expenses.

5. Where is the ENDO Trial being conducted?

The ENDO Trial is being conducted at medical centers throughout the U.S. Please click here to see a list of current study locations.

6. Who can participate in the ENDO Trial?

If you are currently taking oral medication for your type 2 diabetes, and have a Body Mass Index (BMI) between 30 – 55, you may be eligible for the ENDO Trial. To estimate your Body Mass Index (BMI), please use the following BMI Calculator.

7. Who is the company sponsoring the ENDO Trial?

The ENDO Trial is being sponsored by GI Dynamics, Inc., a medical device company headquartered in Lexington, MA (www.gidynamics.com).

8. I am interested in hearing more. What is the next step?

To see if you might be eligible for the ENDO Trial, and to get connected directly with the local study center in your area, the next step is taking the pre-screening questionnaire. Please click here to get started.