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

Status

Terminated

Conditions

Intervention / Treatment

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

Study Locations

    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville

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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abdominal Pain
Time Frame: 4 weeks
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.

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

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.

Clinical Trials on Abdominal Pain

Clinical Trials on Enterra

Subscribe