Study of Enhanced Programming Stimulation with the Enterra® Therapy System (NCT06560307)
Examination of Programming with the Enterra® Therapy System in a Double-Blinded, Randomized, Prospective Study in the Treatment of Nausea and Vomiting Symptoms Using Gastric Electrical Stimulation
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this research study is to evaluate if an enhanced Enterra device programming strategy will improve symptoms associated with gastroparesis, improve symptoms in a faster amount of time, and improve quality of life measures. Participants in this study will be evaluated for study entry criteria, have an Enterra Therapy System implanted, and be randomly assigned to one of two programming strategies. 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 monthly 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 South Florida — Tampa, Florida
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 (6 Sites)
- University of South Florida — Tampa, Florida
- University of Louisville — Louisville, Kentucky
- Henry Ford Health System — Detroit, Michigan
- Washington University — St Louis, Missouri
- Foundation for Surgical Innovation — Portland, Oregon
- Benaroya Research Institute at Virginia Mason — Seattle, Washington
📞 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.