EndoBarrier - Endoscopically Delivered Medical Device for Clinical Trials - Medical / Health Care - Clinical Services
GI Dynamics has taken all necessary COVID-19 precautions to ensure patient safety, which remains top priority. Patient screening for the STEP-1 pivotal trial of EndoBarrier has reopened at select sites and enrollment will be conducted according to site requirements and CDC/FDA guidelines.
Details
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.