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Gastric Electrical Stimulation for Abdominal Pain in Patients With Gastroparesis
Sponsor: University of Louisville
Summary
Gastroparesis is a disorder characterized by delayed gastric emptying and symptoms including nausea, vomiting, and abdominal pain. Gastric electrical stimulation (GES) using the implanted Enterra™ neurostimulator is FDA-approved to treat nausea and vomiting but its impact on abdominal pain has not been well studied. This study evaluates whether alternative programming parameters of the Enterra™ device can reduce abdominal pain in patients with gastroparesis. Participants with an existing Enterra™ device will be randomized to one of three stimulation settings and followed for assessment of pain, gastrointestinal symptoms, quality of life, and medication use.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2026-07
Completion Date
2030-07
Last Updated
2026-05-04
Healthy Volunteers
No
Conditions
Interventions
Enterra™ neurostimulator
Gastric Electrical Stimulation using implanted Enterra™ neurostimulator with protocol-specified programming parameters.
Locations (1)
University of Louisville Clinical Trials Unit
Louisville, Kentucky, United States