Escalating Temporary Gastric Electrical Stimulation (GES) for Severe Gastroparesis



Status:Suspended
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 90
Updated:10/6/2018
Start Date:February 2013
End Date:December 2020

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Escalating Temporary Gastric Electrical Stimulation for Severe Gastroparesis

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),

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
We found this trial at
1
site
600 University Boulevard
Indianapolis, Indiana 46202
Phone: 317-948-9227
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mi
from
Indianapolis, IN
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