- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04121325
Gastric Electrical Stimulation for Abdominal Pain in Gastroparesis
October 24, 2023 updated by: Thomas Abell, University of Louisville
Gastric Electrical Stimulation for Treating Abdominal Pain in Patients With Gastroparesis
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 refractory to drugs and/or devices.
Study Overview
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 symptoms including pain will be evaluated by a daily diary.
At the end of 4 weeks detailed pain assessments and noninvasive physiologic assessments will be repeated.
Study Type
Observational
Enrollment (Actual)
4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Thomas Abell
- Phone Number: (502)852-6991
- Email: thomas.abell@louisville.edu
Study Locations
-
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Kentucky
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Louisville, Kentucky, United States, 40202
- University of Louisville
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Gastroparesis patients with abdominal pain.
Description
Inclusion Criteria:
- 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 Criteria:
- Unable to provide informed consent
- Pregnancy
- Any other active health problems that would render patient unable to complete the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Gastroparesis patients with abdominal pain
Patients with gastroparesis who have had an Enterra device in place for at least two months who continue to have moderate to severe abdominal pain.
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To measure validated and subjective pain scores among patients with an existing GES device, and who have a trial of new settings directed at abdominal pain and compare their pain scores to each patient baseline symptoms, done with their previous GES settings.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Abdominal Pain
Time Frame: 4 weeks
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Abdominal Pain by Brief Pain Inventory.
The values are 0-10, with 10 being worse outcome.
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Thomas Abell, MD, University of Louisville
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 18, 2019
Primary Completion (Actual)
March 13, 2020
Study Completion (Actual)
March 13, 2020
Study Registration Dates
First Submitted
October 4, 2019
First Submitted That Met QC Criteria
October 8, 2019
First Posted (Actual)
October 9, 2019
Study Record Updates
Last Update Posted (Actual)
October 27, 2023
Last Update Submitted That Met QC Criteria
October 24, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19.0915
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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