NCT06560307

Study of Enhanced Programming Stimulation with the Enterra® Therapy System

Examination of Programming with the Enterra® Therapy System in a Double-Blinded, Randomized, Prospective Study in the Treatment of Nausea and Vomiting Symptoms Using Gastric Electrical Stimulation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Enterra Medical, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to evaluate if an enhanced Enterra device programming strategy will improve symptoms associated with gastroparesis, improve symptoms in a faster amount of time, and improve quality of life measures. Participants in this study will be evaluated for study entry criteria, have an Enterra Therapy System implanted, and be randomly assigned to one of two programming strategies. Participants will answer daily questions about their gastroparesis symptoms on an application with their phone/tablet. Participants will answer quality of life questionnaires about their gastroparesis symptoms at monthly study visits. Participants will be involved in the study for up to six months after treatment assignment. Programming parameters in the study are within currently approved labeling.

Conditions

• Gastroparesis
• Gastroparesis Nondiabetic
• Gastroparesis Due to Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Enterra Therapy System	The Enterra® Therapy System for gastric electrical stimulation (GES) is indicated for the treatment of chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology in patients aged 18 to 70 years.

Timeline

• Start date: 2024-07-25
• Primary completion: 2026-10-01
• Completion: 2026-12-01
• First posted: 2024-08-19
• Last updated: 2024-11-15

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study