Gastroparesis
Conditions
Keywords
gastroparesis, gastric electrical stimulator, GES, vomiting, nausea, bloating, postprandial fullness, epigastric pain
Brief summary
The purpose of this study is to determine the physiologic effects of temporary gastric electrical stimulation in subjects with severe gastroparesis.
Detailed description
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),
Interventions
None listed
Sponsors
Indiana University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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\* * retention at 2 hr: \>60% or * retention at 4 hr: \>10% \*Based on International consensus on gastric scintigraphy
Exclusion criteria
* Gastric outlet, small bowel, or colon obstruction. * Small bowel malrotation * Inflammatory bowel disease * Contraindication for surgical implantation of GES * Presence of illness that may require MRI during the study; such as pituitary tumor, herniated disc, spinal stenosis, multiple sclerosis, etc. * Significant comorbidity due to sever cardiovascular, renal, pulmonary, or liver disease. * Significant coagulopathy * Non-ambulatory patients: bed-ridden, nursing home resident, etc. * Pregnancy * Unable to give own informed consent * Prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in the symptoms of gastroparesis by t-GES in patients with severe gastroparesis. | 1 month | Review the symptoms before and after the t-GES placements and follow for any improvement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical response to t-GES placement as measured by questionnaires | 1 year | Measuring the responses to questionnaires before and after placement of GES |
| Develop a prospective registry in patients undergoing escalating t-GES | 1 year | Have a database of patients undergoing t-GES placement |
| determine the feasibility and patient tolerability of endoscopic placement of t-GES | 1 year | Determine if placement of t-GES is feasible and if the patients tolerate the t-GES |
Countries
United States
Outcome results
None listed