Study of Enterra Programming with Nocturnal Cycling in Gastroparetics (NCT05980455)
Randomized Study of Enterra Programming with Nocturnal Cycling in Gastroparetics
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Louisville — Louisville, Kentucky
Age range: 18 Years to 70 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (2 Sites)
- University of Louisville — Louisville, Kentucky
- MNGI Digestive Health, P.A. — Coon Rapids, Minnesota
📞 Contact the Study Coordinator
Phone: (855) 768-3772
Email: clinicalresearch@enterramedical.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Gastroparesis
- Cardiac Vagal Effects of GES in Patients With Gastroparesis and Vagal Nerve Action Potentials in Vagus Nerve — Indianapolis, Indiana
- Vagus Nerve Response in Gastroparesis Patients — Indianapolis, Indiana
- ABVN Phase 2-Studying the Effect of Stimulation on the Auricular Branch of the Vagal Nerve — Indianapolis, Indiana
- Combined Role of Gastric Peroral Endoscopic Myotomy and Gastric Electrical Stimulator — Dallas, Texas
- Magnetic Resonance Imaging of the Brain and Stomach in Healthy Volunteers and Gastroparesis — Indianapolis, Indiana
- Endoscopic Myotomy of the Pylorus To Improve Emptying and Symptoms Trial — Cleveland, Ohio
Explore by condition: All Gastroparesis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.