Clinical Trial

Gastric Electrical Stimulation for Abdominal Pain in Patients With Gastroparesis

Study acronym: HEAL
Not Yet Recruiting
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-04-21.
Trial Details
NCT Number NCT07556237
Lead Sponsor University of Louisville
Collaborators: National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)
Conditions Gastroparesis, Chronic Abdominal Pain
Enrollment 150 participants
Start Date 2026-07
Primary Completion 2030-07 (estimated)
Study Completion 2030-07 (estimated)
Updated on ClinicalTrials.gov 2026-05-04