Indiana University Gastric Electrical Stimulation Registry

Last updated: April 11, 2024
Sponsor: Indiana University
Overall Status: Active - Enrolling

Phase

N/A

Condition

Gastroparesis

Treatment

N/A

Clinical Study ID

NCT05047289
2008529997
  • Ages 18-80
  • All Genders

Study Summary

The purpose of this study is to develop a clinical registry in patients with Gastric Electrical Stimulation (GES) therapy for gastroparesis to support future gastrointestinal therapies, medical procedures and diagnostics.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients undergo implantation of a new GES device for medical refractory gastroparesis

Exclusion

Exclusion Criteria:

  • Non-ambulatory patients: bed-ridden, nursing home resident, etc.
  • Pregnancy
  • Unable to give own informed consent.
  • Prisoners

Study Design

Total Participants: 1000
Study Start date:
October 20, 2020
Estimated Completion Date:
October 20, 2030

Study Description

This study will evaluate male and female patients at least 18 years of age, with gastroparesis, who will or have already undergone the implantation of a GES device

The study will be conducted at one center and approximately 1,000 subjects will be enrolled.

Subjects undergoing the GES implantation will be enrolled before the implantation and may have a baseline visit. The visit procedures will be conducted at the discretion of the investigator dependent on the clinical condition of the patient at that time.

Connect with a study center

  • Indiana University Hospital

    Indianapolis, Indiana 46202
    United States

    Site Not Available

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