Randomized Study of Enterra Programming with Nocturnal Cycling in Gastroparetics
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.
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
In order to be eligible to participate in this study, a participant must meet all of the following criteria: 1. Completed informed consent process with signed and dated informed consent form; 2. Stated willingness to comply with all study procedures and availability for the duration of the study; 3. Male or female, aged ≥18 or ≤70 at time of informed consent; 4. Currently implanted with the Enterra® Therapy System (Enterra® II 37800 neurostimulator); 5. High GES output defined as remaining pulse generator expected life of \> 9 months from enrollment and less than 4 years from the time of impl…
Interventions
- DeviceEnterra® 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 LouisvilleLouisville, Kentucky
- MNGI Digestive Health, P.A.Coon Rapids, Minnesota