Gastric Electrical Stimulation for Abdominal Pain in Gastroparesis

This study is looking at whether different settings for the Enterra™ neurostimulator can help reduce chronic abdominal pain in people with gastroparesis (a condition where your stomach empties too slowly, causing symptoms like nausea and pain). The Enterra™ device is already approved to treat nausea and vomiting, but its effect on pain isn't well understood. You might be able to join if you are an adult aged 18 or older, have been diagnosed with gastroparesis, already have an Enterra™ device implanted for at least 8 weeks, and experience daily abdominal pain of gastric origin with an average pain score of 4 or higher. The main goal is to see how much your abdominal pain score changes from the beginning of the study to 8 weeks later. The current recruitment status is unclear.

Study design
This is a randomized, double-blind study where participants are assigned to one of three Enterra™ device settings. About 150 people are expected to join.
What's involved
You would first use your current device settings for two weeks. Then, you would use your assigned study settings for eight weeks, during which you'd report on your pain, symptoms, quality of life, and medication use.
Compensation
Not stated in the trial record.
Follow-up
After the 8-week blinded assessment, you may choose your preferred settings for an additional 8-week follow-up period.

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NCT07556237

Gastric Electrical Stimulation for Abdominal Pain in Patients With Gastroparesis

Not Yet Recruiting
NAAges 18+InterventionalTreatment
University of Louisville
~150 participants
Updated 2026-05-04 on ClinicalTrials.gov
What's tested:Enterra™ neurostimulator

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Abdominal Pain Score
Measured over Baseline to 8 weeks after randomization.
Gastroparesis
Chronic Abdominal Pain
1 sites across 1 states
Kentucky1

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Eligibility criteria

Inclusion

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

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.
  • Change in Abdominal Pain ScoreBaseline to 8 weeks after randomization.

    Change from baseline in seven-day average of daily worst abdominal pain score measured using an 11-point Numeric Rating Scale (0 = no pain, 10 = worst possible pain).