Study of Enhanced Programming Strategies Using the Enterra Therapy System to Treat Nausea and Vomiting Symptoms in Gastroparesis Patients Aged 18 to 70

What this Trial Is About

Researchers are evaluating an enhanced programming strategy for the Enterra Therapy System to see if it improves symptoms of gastroparesis, such as nausea and vomiting, more quickly and enhances quality of life. This study involves adults aged 18 to 70 with idiopathic or diabetic gastroparesis who have had delayed gastric emptying and normal endoscopy results. The research is a randomized, double-blind, prospective study sponsored by Enterra Medical, Inc. Participants will have the Enterra Therapy System implanted and be randomly assigned to one of two programming strategies. One group starts with nominal lower stimulation settings and continues with slight increases at 3 months and later visits. The other group begins with nominal settings but receives moderate increases in stimulation amplitude and duty cycle at treatment assignment, with further adjustments at follow-ups. Programming settings are within approved device labeling. Participants will be involved for up to six months after treatment assignment. They will answer daily symptom questions via a smartphone or tablet app and complete quality of life questionnaires at monthly visits. Researchers will monitor changes in vomiting frequency, nausea severity, total symptom scores, and quality of life at 1, 3, and 6 months. Safety and response to stimulation will also be assessed throughout the study.

Study of Enhanced Programming Stimulation with the Enterra® Therapy System