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Study of Enterra Programming with Nocturnal Cycling in Gastroparetics
Sponsor: Enterra Medical, Inc.
Summary
The purpose of this research study is to evaluate if different Enterra® device programming methods active during sleeping hours can maintain gastroparesis-related symptom relief and quality of life measures. Participants in this study with existing Enterra® devices will be randomly assigned to one of three programming methods that will be active during sleep. 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 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.
Official title: Randomized Study of Enterra Programming with Nocturnal Cycling in Gastroparetics
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2023-07-10
Completion Date
2025-12
Last Updated
2024-11-15
Healthy Volunteers
No
Interventions
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.
Locations (2)
University of Louisville
Louisville, Kentucky, United States
MNGI Digestive Health, P.A.
Coon Rapids, Minnesota, United States