Indiana University Gastric Electrical Stimulation Registry
Study of a Registry for Gastric Electrical Stimulation in Adults With Gastroparesis
Brief description of 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.
Detailed description of study
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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Gastroparesis
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Age: 18 years - 80 years
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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
The purpose of this research study is to create a clinical registry of adults with gastroparesis who receive gastric electrical stimulation (GES) therapy. A registry is a way to collect and organize health information over time.
Participants will be adults who are planning to have a GES device implanted or who have already had one implanted. People who are having the device implanted will be enrolled before the implantation and may have a baseline visit. Visit procedures will depend on the person’s clinical condition at the time, based on the study doctor’s judgment. This study is being done at 1 center and plans to enroll about 1,000 people.
Who can participate:
Adults with gastroparesis may be able to participate if they:
- Are age 18 or older
- Have gastroparesis that has not improved enough with medical treatment and are getting a new GES device implanted
Interested in the study?
This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.
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