- GI Dynamics has signed a contract with Brigham and Women’s Hospital in Boston to be the lead clinical site of the U.S pivotal trial of EndoBarrier
- EndoBarrier is a medical device aimed at Type 2 Diabetes patients or people suffering obesity
- The device is expected to bridge the gap between pharmaceuticals and surgery
- Patients will be enrolled in the trial in the second half of 2019
GI Dynamics has signed a contract with Brigham and Women’s Hospital in Boston to be the lead clinical site of the U.S pivotal trial of EndoBarrier.
EndoBarrier is the first endoscopically-delivered device therapy to treat type 2 diabetes and obesity. The medical device is a thin, plastic sleeve which lines the first part of the small intestine, causing food to be absorbed further down. Blocking this part of the intestine will make you feel fuller for longer, thus promoting portion control and a reduction in blood sugar levels.
The U.S pivotal trial of EndoBarrier, STEP-1 will begin enrolling patients during the second half of 2019. It will trial whether patients’ blood sugar levels reduce within a 12-month period.
GI Dynamics is pleased to be partnering with Brigham and Women’s for the trial.
“Brigham and Women’s is one of the top treatment facilities in the U.S. and a leader in minimally invasive gastrointestinal procedures. It is an honour to have their
outstanding team as our lead clinical site for STEP-1,” GI Dynamics’ Vice President of Clinical and Regulatory Affairs Stephen Linhares said.
As of 2018, 1.5 million Americans are diagnosed with diabetes each year. It remains the seventh leading cause of death in the U.S. For most of these people, surgery is not an option. If approved for sale, EndoBarrier is expected to bridge the gap between pharmaceuticals and surgery.
The principal investigator for the STEP-1 trial is Dr. Thompson. Dr. Thompson has written over 200 publications and has participated in or led many clinical trials.
“It is imperative to find new ways to treat type 2 diabetes and obesity and I believe EndoBarrier will help pave the way,” Dr. Thompson said.