Gastric Electrical Stimulation for Abdominal Pain in Gastroparesis

NCT04121325 | Terminated FDA Device

• 1 other identifier: 19.0915
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Pain

Outcome Measures

Primary Outcomes (1)

• Abdominal Pain

  Abdominal Pain by Brief Pain Inventory. The values are 0-10, with 10 being worse outcome.

  4 weeks

Study Arms (1)

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.

Device: Enterra

Interventions

Enterra 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.

Gastroparesis patients with abdominal pain

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Gastroparesis patients with abdominal pain.

You may qualify if:

• 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

You may not qualify if:

• Unable to provide informed consent
• Pregnancy
• Any other active health problems that would render patient unable to complete the study

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Abdominal Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Thomas Abell, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 4, 2019
• First Posted: October 9, 2019
• Study Start: December 18, 2019
• Primary Completion: March 13, 2020
• Study Completion: March 13, 2020
• Last Updated: October 27, 2023

Record last verified: 2023-10

Locations

US (1)