Most recent update: Friday, August 23, 2019 - 09:44

Bariatric News - Cookies & privacy policy

You are here

EndoBarrier Pivotal Trial

GI Dynamics gains IRB approval for EndoBarrier Pivotal Trial

IRB approval is required by the FDA and is an essential step to allow the EndoBarrier pivotal trial to proceed.

GI Dynamics has received Institutional Review Board (IRB) approval to conduct its pivotal trial of EndoBarrier for type 2 diabetes and obesity. The pivotal trial of EndoBarrier, referred to as the 18-1 study, is a randomised (3:1) controlled double-blinded clinical trial designed to measure the efficacy and safety of EndoBarrier in conjunction with lifestyle therapy and diabetes medication for the treatment of type 2 diabetes and obesity vs. a sham control arm in conjunction with lifestyle therapy and diabetes medication, also for the treatment of type 2 diabetes and obesity.

The 18-1 study will occur in two stages: stage I consists of 50 EndoBarrier patients and approximately 17 control patients and will be completed with the filing of four Data Monitoring Committee (DMC) reports with the US Food and Drug Administration (FDA). Upon review of the four DMC reports by the FDA, the company will apply for approval to conduct Stage II of the trial, which is projected to include the balance of patients to complete the 18-1 study total of 240 patients (180 EndoBarrier and 60 control).

IRB approval is required by the FDA and is an essential step to allow the EndoBarrier pivotal trial to proceed. Western IRB (WIRB) is serving as the company’s central IRB. GI Dynamics was notified that the following EndoBarrier pivotal trial documentation is approved by WIRB: protocol, informed consent form and investigator’s brochure.

“When we announced that the FDA approved our Investigational Device Exemption (IDE) for the pivotal trial of EndoBarrier, the approval was conditional upon IRB approval,” said Scott Schorer, president and chief executive officer of GI Dynamics. “This IRB approval now satisfies that condition. In parallel, we continue to push forward with the clinical study sites that will be part of the 18-1 study and we anticipate being in a position to announce these clinical sites shortly.”

Want more stories like this? Subscribe to Bariatric News!

Bariatric News
Keep up to date! Get the latest news in your inbox. NOTE: Bariatric News WILL NOT pass on your details to 3rd parties. However, you may receive ‘marketing emails’ sent by us on behalf of 3rd parties.