Study Begins for Enterra Medical’s Chronic Nausea Treatment Device

Enterra Medical Inc. has begun a U.S. Food and Drug Administration (FDA)-approved IDE study of its Gastric Electrical Stimulation (GES) solution for treating chronic nausea with normal gastric emptying. Granted FDA Breakthrough Device Designation, the NAVIGATE clinical trial and its potential therapy indication represent a promising advancement for a patient population with extremely limited treatment options, according to the company.

The NAVIGATE study will assess whether the company’s Enterra Therapy System provides safe and effective improvement for nausea severity, vomiting frequency, and quality of life measures for individuals who have not found relief through available diet and drug therapies. Unlike previous GES studies that focused on patients with refractory gastroparesis, this study is evaluating patients who experience chronic nausea with severe symptoms, despite normal gastric emptying. Importantly, NAVIGATE also allows enrollment of patients who have previously undergone pyloric interventions.

“Patients 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’ symptoms as previously believed,” said Prof. Jan Tack, the study’s global principal investigator. While patients with refractory gastroparesis have been treated with GES for more than two decades, the NAVIGATE study aims to expand the patient population that may benefit from GES therapy.

NAVIGATE is a multi-center, randomized, double-blind, placebo-controlled study that will enroll at least 148 subjects throughout the United States, Europe, and United Kingdom. The first patient was enrolled at the University of Louisville by gastroenterologist Dr. Abigail Stocker and surgeon Dr. John Olsofka.

Enterra Therapy was approved by FDA in 2000 under a Humanitarian Device Exemption (HDE). Called Gastric Electrical Stimulation (GES), Enterra Therapy delivers mild electrical pulses to the nerves and smooth stomach muscles to control the chronic nausea and vomiting symptoms associated with gastroparesis.

Enterra Medical was founded in 2022 to help treat chronic nausea and vomiting.