Medical devices developer GI Dynamics has announced that the US STEP-1 clinical trial has enrolled the first patient of its EndoBarrier implant.
EndoBarrier is an endoscopically delivered device designed to treat type 2 diabetes and obesity.
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The randomised and controlled, double-blinded pivotal trial is being carried out at Michigan Medicine in Ann Arbor, Michigan.
Gastroenterology and internal medicine assistant professor and principal investigator Dr Allison R Schulman are leading the trial.
Dr Schulman said: “We are honoured to be the first clinical study site to enrol the first patient into the STEP-1 trial.
“This groundbreaking trial is the first of its kind to measure the primary endpoint of type 2 diabetes combined with reductions in weight, cardiovascular risk, non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH) and chronic kidney disease (CKD).
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By GlobalData“I am excited to help bring an interventional upper gastrointestinal implant procedure for the treatment of multiple metabolic disorders to this patient population.”
STEP-1 trial is intended to evaluate the safety and efficacy of EndoBarrier in coexistence with lifestyle therapy and diabetes medication.
During stage one of the trial, 67 patients will be recruited, with each patient receiving identical diabetes medication monitoring and counselling over a treatment period of two years.
GI Dynamics president and CEO Scott Schorer said: “In addition to measuring the primary endpoint of reduction in blood sugar at 12 months, this landmark study measures a wide variety of metabolic conditions across a two-year period, the first pivotal trial in the U.S. to do so.
“We hope to gather evidence to support future research of metabolic disorders and data to support approval in the US through post-market approval.”
The outcomes from the trial will support GI Dynamics’s pre-market approval application for EndoBarrier to the US Food and Drug Administration (FDA).
The company plans to complete the enrolment by the end of this year.
