Indiana University Gastric Electrical Stimulation Registry

Sponsor
Indiana University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05047289
Collaborator
Purdue University (Other)
1,000
1
120
8.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Indiana University Gastric Electrical Stimulation Registry
    Actual Study Start Date :
    Oct 20, 2020
    Anticipated Primary Completion Date :
    Oct 20, 2030
    Anticipated Study Completion Date :
    Oct 20, 2030

    Outcome Measures

    Primary Outcome Measures

    1. To develop a clinical registry in patients with GES therapy [3 years]

      The purpose of this study is to develop a clinical registry in patients with Gastric Electrical Stimulation (GES) therapy for gastroparesis to support future clinical and translational research. Gastroparesis is an illness caused by a delay of stomach emptying. Symptoms of gastroparesis include nausea, vomiting, weight loss, the feeling of being full right away when you start eating, and abdominal pain. The disease may also lead to malnutrition and weight loss. GES has shown promise in patients with gastroparesis. However, how the GES works is unclear, but the patients who undergo GES show improvement in their symptoms.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients undergo implantation of a new GES device for medical refractory gastroparesis
    Exclusion Criteria:
    • Non-ambulatory patients: bed-ridden, nursing home resident, etc.

    • Pregnancy

    • Unable to give own informed consent.

    • Prisoners

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Indiana University Hospital Indianapolis Indiana United States 46202

    Sponsors and Collaborators

    • Indiana University
    • Purdue University

    Investigators

    • Principal Investigator: John Wo, MD, Indiana University School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    John M. Wo, Director, GI Motility and Neurogastroenterology, Indiana University
    ClinicalTrials.gov Identifier:
    NCT05047289
    Other Study ID Numbers:
    • 2008529997
    First Posted:
    Sep 17, 2021
    Last Update Posted:
    Mar 2, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by John M. Wo, Director, GI Motility and Neurogastroenterology, Indiana University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 2, 2022