Status:
TERMINATED
Gastric Electrical Stimulation for Abdominal Pain in Gastroparesis
Lead Sponsor:
University of Louisville
Conditions:
Abdominal Pain
Eligibility:
All Genders
18-70 years
Brief Summary
To conduct a pilot study to evaluate the effects of new GES programming settings on abdominal pain in patients with gastroparesis and existing GES devices, whose abdominal pain has so far been refract...
Detailed Description
Eligible patients will undergo detailed pain assessments as well as non-invasive physiologic assessment. Patients existing GES devices will be reprogrammed to new setting for 4 week and their GI sympt...
Eligibility Criteria
Inclusion
- Should be able to give informed consent for the study
- Has Enterra GES device in place for at least 2 months
- Continue to have moderate to severe abdominal pain on at least one pain questionnaire or \>5 score (on a scale of 0-10 for pain) on the VAS questionnaire for at least 2 months.
- Abdominal pain should be either persistent; for example, daily for at least \>1 hour, be chronic for \>2 months, and refractory to original Enterra GES settings
Exclusion
- Unable to provide informed consent
- Pregnancy
- Any other active health problems that would render patient unable to complete the study
Key Trial Info
Start Date :
December 18 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 13 2020
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04121325
Start Date
December 18 2019
End Date
March 13 2020
Last Update
October 27 2023
Active Locations (1)
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1
University of Louisville
Louisville, Kentucky, United States, 40202