Study of the Enterra Therapy System for Treating Chronic Nausea and Vomiting in Adults with Normal Gastric Emptying

What this Trial Is About

This research investigates whether the Enterra Therapy System can reduce nausea and vomiting symptoms and improve quality of life in patients who experience chronic nausea with normal gastric emptying. The study focuses on patients whose symptoms have been persistent, drug-resistant, and active recently, aiming to assess the devices impact on these symptoms over time. Participants will have the Enterra Therapy System implanted, a gastric electrical stimulator consisting of an implantable pulse generator and leads, programmed and adjusted by clinicians. They will be randomly assigned to one of two groups an ON group receiving initial device stimulation, or an OFF group starting with the device turned off and later switched on. Adjustments to device programming will occur at follow-up visits, with individualized therapy settings introduced after initial study periods. Throughout about twelve months of participation, patients will regularly report their nausea and vomiting symptoms and quality of life impacts using a smart device and complete questionnaires during study visits. Researchers will monitor changes in nausea severity, vomiting frequency, total symptom scores, and quality of life scores at 4 and 12 months. This ongoing assessment helps evaluate the effects of the therapy system while ensuring patient safety and adherence to study protocols.

Chronic Nausea and Vomiting in Patients With Normal Gastric Emptying Using the Enterra® Therapy System (NAVIGATE)