Study of Enterra Programming with Nocturnal Cycling in Gastroparetics
Recruiting now · Not applicable
Conditions studied: Gastroparesis, Gastroparesis Nondiabetic, Gastroparesis Due to Diabetes Mellitus
In brief
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.
Key facts
- Study ID
- NCT05980455
- Run by
- Enterra Medical, Inc.
- People needed
- 50
- Starts
- 2023-07-10
- Expected to finish
- 2025-12-01
- Last updated by the study team
- 2024-11-15
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of Louisville — Louisville, Kentucky, United States (enrolling)
- MNGI Digestive Health, P.A. — Coon Rapids, Minnesota, United States (enrolling)
Full record on ClinicalTrials.gov
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