Indiana University Gastric Electrical Stimulation Registry
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 |
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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
Outcome Measures
Primary Outcome Measures
- 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
Inclusion Criteria:
- Patients undergo implantation of a new GES device for medical refractory gastroparesis
Exclusion Criteria:
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Non-ambulatory patients: bed-ridden, nursing home resident, etc.
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Pregnancy
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Unable to give own informed consent.
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Prisoners
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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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.- 2008529997