Indiana University Gastric Electrical Stimulation Registry

NCT05047289 | Enrolling By Invitation

• 1 other identifier: 2008529997
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroparesis

Keywords

gastroparesis; gastric electrical stimulator; GES; vomiting; nausea; bloating; post prandial fullness; epigastric pain

Outcome Measures

Primary Outcomes (1)

• To develop a clinical registry in patients with GES therapy

  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.

  3 years

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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 (Enterra, Medtronic, Minneapolis, MN)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Indiana University: lead
• Purdue University: collaborator

Study Sites (1)

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Gastroparesis; Vomiting; Nausea

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• John Wo, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, GI Motility and Neurogastroenterology

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: September 17, 2021
• Study Start: October 20, 2020
• Primary Completion (Estimated): October 20, 2030
• Study Completion (Estimated): October 20, 2030
• Last Updated: April 12, 2024

Record last verified: 2024-04

Locations

US (1)