Enterra Medical has commenced the randomised, multi-centre NAVIGATE study, designed to assess Gastric Electrical Stimulation (GES) for the treatment of individuals with chronic nausea with normal gastric emptying.
The placebo-controlled, double-blind study was approved by the US Food and Drug Administration (FDA) as an investigational device exemption (IDE) trial and was awarded breakthrough device designation.
It will explore whether the Enterra Therapy System, called GES, can significantly improve nausea severity, frequency of vomiting, and quality of life for those who are unresponsive to current diet and drug therapies.
This marks a shift from previous GES trials, which primarily aimed at refractory gastroparesis patients, to include those with severe chronic nausea symptoms despite normal gastric function.
The current study facilitates the enrolment of individuals who have undergone pyloric interventions before.
Set to enrol a minimum of 148 individuals, the study will be carried out across medical institutions in the UK, Europe, and the US.
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By GlobalDataThe University of Louisville in the US has enrolled the first subject by surgeon Dr John Olsofka, and gastroenterologist Dr Abigail Stocker.
NAVIGATE study global principal investigator professor Jan Tack said: 鈥淧atients with normal gastric emptying can experience symptoms equally severe as those with delayed emptying, making us question if gastric emptying status is as central to patients鈥� symptoms as previously believed.鈥�
For more than 20 years, patients with refractory gastroparesis have received treatment through GES, and the study seeks to broaden the range of patients who could gain advantages from this therapy.
In 2000, Enterra Therapy secured approval from the US regulator through a Humanitarian Device Exemption.
The therapy delivers mild electrical pulses to the stomach’s nerves and muscles to alleviate chronic nausea and vomiting symptoms in gastroparesis patients.
