GI Dynamics' ongoing clinical trial of EndoBarrier Therapy has been placed on hold, preventing further enrollment, by the FDA.
Here are four things to know:
1. EndoBarrier Therapy is an endoscopically-delivered device therapy for those suffering from uncontrolled type-2 diabetes and obesity.
2. The decision to hold further enrollment is due to the fact that there have been four cases of hepatic abscess among the 325 subjects currently enrolled in the ENDO Trial.
3. The FDA is thus requesting additional information to further assess the risk/benefit profile of the EndoBarrier Therapy.
4. According to a press release, GI Dynamics has already implemented several risk mitigation strategies in the ENDO Trial and is working to submit the requested information to the FDA.