Gastric Electrical Stimulation for Abdominal Pain in Patients With Gastroparesis
Not yet recruitingNot applicableNCT07556237
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Gastric Electrical Stimulation for Abdominal Pain in Patients With Gastroparesis
- Conditions
- Gastroparesis
- Chronic Abdominal Pain
- Interventions
- Device: Enterra™ neurostimulator
- Sponsor
- University of Louisville
- Collaborators
- National Institutes of Health (NIH); National Institute of Neurological Disorders and Stroke (NINDS)
- Start date
- 2026-07
- Primary completion
- 2030-07
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Adults aged 18 years or older. * Diagnosed gastroparesis. * Implanted Enterra™ device for at least 8 weeks prior to enrollment. * Chronic daily abdominal pain of gastric origin lasting more than 2 months. * Average pain score ≥4 on a 0-10 scale. * Ability to provide informed consent. Exclusion Criteria: * Daily opioid use. * Pregnancy or breastfeeding. * Abdominal pain not attributed to gastric/visceral origin. * Severe constipation or uncontrolled diabetes (HbA1c \>10). * Other medical conditions that would interfere with study participation.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07556237