Study of Enhanced Programming Stimulation with the Enterra® Therapy System
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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.
Eligibility
Primary outcome measure(s)
- Change in Vomiting Absolute Frequency — 3 Months
As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) weekly vomiting absolute frequency - Change in Nausea Severity Score — 3 Months
As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) nausea severity score
Trial sites (6)
| Facility | City | Region | Status |
|---|---|---|---|
| University of South Florida | Tampa | Florida | Recruiting |
| University of Louisville | Louisville | Kentucky | Recruiting |
| Henry Ford Health System | Detroit | Michigan | Recruiting |
| Washington University | St Louis | Missouri | Recruiting |
| Foundation for Surgical Innovation | Portland | Oregon | Recruiting |
| Benaroya Research Institute at Virginia Mason | Seattle | Washington | Recruiting |
More Enterra Medical, Inc. trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06560307 on ClinicalTrials.gov ↗ ← All trials in the USA