Gastric Electrical Stimulation for Abdominal Pain in Gastroparesis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

4 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-18

Study Completion Date

2020-03-13

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Abdominal Pain

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Enterra

Intervention Type DEVICE

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.

Interventions

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Enterra

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.

Intervention Type DEVICE

Eligibility Criteria

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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