Escalating Temporary Gastric Electrical Stimulation (GES) for Severe Gastroparesis
- Conditions
- Gastroparesis
- Registration Number
- NCT02164591
- Lead Sponsor
- Indiana University
- 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),
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 19
-
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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Clinical response to t-GES placement as measured by questionnaires 1 year Measuring the responses to questionnaires before and after placement of GES
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
Develop a prospective registry in patients undergoing escalating t-GES 1 year Have a database of patients undergoing t-GES placement
Trial Locations
- Locations (1)
Indiana University Hosptial
🇺🇸Indianapolis, Indiana, United States