Enterra Programming for Gastroparesis with Nocturnal Cycling
This study is looking at different ways to program the Enterra® Therapy System, a device used to treat gastroparesis (a condition where your stomach empties too slowly). Specifically, researchers want to see if programming the device to be active during sleeping hours can continue to help with symptoms like nausea and vomiting, and improve your quality of life. If you already have an Enterra® device, you might be able to join this study. You would be randomly assigned to one of three programming methods. The study will measure changes in your weekly vomiting frequency and how severe your nausea is over 3 and 6 months. The study aims to enroll 50 participants and its current status is unclear.
- Study design
- This interventional study will randomly assign participants with existing Enterra® devices to one of three programming methods. It plans to enroll 50 participants.
- What's involved
- You will answer daily questions about your symptoms using a phone/tablet app and complete quality of life questionnaires at study visits. Your involvement will last up to six months after being assigned a treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your symptoms will be measured at 3 and 6 months after treatment assignment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study of Enterra Programming with Nocturnal Cycling in Gastroparetics
At a glance
Conditions
Where it's being run
2 sites across 2 statesStudy leadership
- Abigail Stocker, MD · PRINCIPAL_INVESTIGATOR · University of Louisville
Who to contact
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What this trial measures
- Percent Change in Weekly Vomiting Frequency by GCSI-DD3 Months, 6 Months
Less than a 50% increase in GCSI-DD weekly vomiting frequency from baseline
- Scoring Change in Nausea Severity by GCSI-DD3 Months, 6 Months
Less than a 1-point increase in GCSI-DD nausea severity from baseline