Gastric Electrical Stimulation for Abdominal Pain in Patients With Gastroparesis

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Conditions studied: Gastroparesis, Chronic Abdominal Pain

In brief

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 facts

Study ID

NCT07556237

Run by

University of Louisville

People needed

150

Starts

2026-07-01

Expected to finish

2030-07-01

Last updated by the study team

2026-05-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Louisville Clinical Trials Unit — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

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