Indiana University Gastric Electrical Stimulation Registry

J
John Wo, MD

Primary Investigator

Enrolling By Invitation
18 years - 80 years
All
Phase N/A
100 participants needed
5 Locations

Brief description of study

What is the purpose of this study?
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. This clinical registry will 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. Gastric electrical stimulation (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.  
 
THIS STUDY IS ENROLLING BY INVITATION ONLY - 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. Subjects will be identified through the EMR, Cerner, and will be given the study information sheet virtually online or in person. 

Detailed description of study

What will happen during the study?
  • 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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Gastroparesis
  • Age: 18 years - 80 years
  • Gender: All

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

Updated on 21 Apr 2025. Study ID: GI-IIR-GES-REGISTRY, 2008529997
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