Gastric Electrical Stimulation for Abdominal Pain in Gastroparesis

Terminated

• Conditions: Abdominal Pain
• Interventions: Device: Enterra

• Registration Number: NCT04121325
• Lead Sponsor: University of Louisville

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 refractory to drugs and/or devices.

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 Timeline

• Study First Submitted: 2019-10-04
• Study First Submitted QC: 2019-10-08
• Study First Posted: 2019-10-09
• Study Start: 2019-12-18
• Primary Completion: 2020-03-13
• Study Completion: 2020-03-13
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-24
• Last Update Posted: 2023-10-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Gastroparesis patients with abdominal pain	Enterra	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.

Primary Outcome Measures

Name	Time	Method
Abdominal Pain	4 weeks	Abdominal Pain by Brief Pain Inventory. The values are 0-10, with 10 being worse outcome.

Trial Locations

Locations (1)

University of Louisville; 🇺🇸 Louisville, Kentucky, United States