Different stimulator settings for belly pain in people with gastroparesis
Tests different Enterra™ stimulator settings for belly pain in gastroparesis.
Key facts
- Who runs it
- University of Louisville
- Where
- Louisville, United StatesSee the site
- Trial code
- Registry title
- Gastric Electrical Stimulation for Abdominal Pain in Patients With Gastroparesis
- Status
- Not yet recruiting
- People taking part
- 150 people, planned
- Started
- Jul 2026
- Expected to end
- Jul 2030
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Enterra™ neurostimulator
- Record updated
- 4 May 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with gastroparesis (slow stomach emptying) who already have an Enterra™ stomach stimulator and daily stomach pain.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- Diagnosed gastroparesis with chronic daily abdominal pain coming from the stomach for more than 2 months. Average pain score of 4 or more on a 0-10 scale.
- Earlier treatment
- An Enterra™ device must have been implanted for at least 8 weeks before joining.
Main reasons for not taking part
- Daily opioid use
- Pregnancy or breastfeeding
- Abdominal pain not coming from the stomach or inner organs
- Severe constipation or uncontrolled diabetes (HbA1c >10)
- Other medical conditions that would get in the way of taking part
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- Other medical conditions that would interfere with study participation
- Severe constipation or uncontrolled diabetes (HbA1c >10)
- Daily opioid use
- Pregnancy or breastfeeding
- Abdominal pain not attributed to gastric/visceral origin
Where in United States
- University of Louisville, Clinical Trials UnitLouisville, United StatesContact: Thomas L Abell, MDNot yet recruiting
About the trial
What the trial wants to find out
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.
The 3 groups in the trial
- Nominal GES ParametersExisting treatment, for comparison
Continuous 24-hour gastric electrical stimulation using participants' standard clinically prescribed Enterra™ settings.
Treatment: Enterra™ neurostimulator
- Special Parameter GESTreatment being tested
Short-cycle stimulation (0.3 seconds on / 0.2 seconds off; 0.24 ms pulse width; 100 Hz frequency; 4-6 mA amplitude) delivered for one hour every eight hours, with nominal settings used during remaining time.
Treatment: Enterra™ neurostimulator
- Modified Enterra ParametersTreatment being tested
Continuous 24-hour stimulation (3 seconds on / 2 seconds off; 0.33 ms pulse width; 14 Hz frequency; 15-20 mA amplitude).
Treatment: Enterra™ neurostimulator
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Gastric Electrical Stimulation for Abdominal Pain in Patients With Gastroparesis
- Plain-language title
- Different stimulator settings for belly pain in people with gastroparesisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 4 May 2026