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The purpose of this study is to determine the physiologic effects of temporary gastric electrical stimulation in subjects with severe gastroparesis.
This study will look to determine the clinical benefit placing temporary gastric electrical stimulation, the ability to predict the clinical response to surgical implantation of GES, and the feasibility and patient tolerability of endoscopic placement of temporary Gastric Electrical Stimulator (t-GES),
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| Measure | Description | Time Frame |
|---|---|---|
| Improvement in the symptoms of gastroparesis by t-GES in patients with severe gastroparesis. | Review the symptoms before and after the t-GES placements and follow for any improvement | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response to t-GES placement as measured by questionnaires | Measuring the responses to questionnaires before and after placement of GES | 1 year |
| Develop a prospective registry in patients undergoing escalating t-GES |
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Inclusion Criteria:
At least 3 months of gastroparesis-related symptoms, such as nausea, emesis, and/or retching
Solid phase 4-hr gastric scintigraphy is consistent with gastroparesis within 3 months of study enrollment*
Exclusion Criteria:
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Subjects who have been diagnosed with gatroparesis.
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| Name | Affiliation | Role |
|---|---|---|
| John M Wo, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Hosptial | Indianapolis | Indiana | 46202 | United States |
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| ID | Term |
|---|---|
| D018589 | Gastroparesis |
| D014839 | Vomiting |
| D009325 | Nausea |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
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Serum to be frozen
Have a database of patients undergoing t-GES placement
| 1 year |
| determine the feasibility and patient tolerability of endoscopic placement of t-GES | Determine if placement of t-GES is feasible and if the patients tolerate the t-GES | 1 year |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |