Gastric Electrical Stimulation for Abdominal Pain in Patients With Gastroparesis

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
University of Louisville
Study ID
NCT07556237
Status
Not Yet Recruiting

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Conditions

  • Chronic Abdominal Pain
  • Gastroparesis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Enterra™ neurostimulator — DEVICE
    Gastric Electrical Stimulation using implanted Enterra™ neurostimulator with protocol-specified programming parameters.

Study Details

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 Dates

Start date
Jul 31, 2026
Status verified
Apr 2026
Primary completion
Jul 31, 2030
Completion
Jul 31, 2030

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Nominal GES Parameters
    Continuous 24-hour gastric electrical stimulation using participants' standard clinically prescribed Enterra™ settings.
  • Experimental: Special Parameter GES
    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.
  • Experimental: Modified Enterra Parameters
    Continuous 24-hour stimulation (3 seconds on / 2 seconds off; 0.33 ms pulse width; 14 Hz frequency; 15-20 mA amplitude).

Primary Outcome Measure

Change in Abdominal Pain Score [ Time Frame: Baseline to 8 weeks after randomization. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Louisville Clinical Trials UnitLouisvilleKentucky40202
Thomas L Abell, MD
[email protected]
502-588-4600

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By research site
University of Louisville Clinical Trials Unit· Louisville, KY

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