Escalating Temporary Gastric Electrical Stimulation (GES) for Severe Gastroparesis

Stopped early

Conditions studied: Gastroparesis

In brief

The purpose of this study is to determine the physiologic effects of temporary gastric electrical stimulation in subjects with severe gastroparesis.

Key facts

Study ID

NCT02164591

Run by

Indiana University

People needed

19

Starts

2013-02-01

Expected to finish

2019-01-01

Last updated by the study team

2020-08-04

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Indiana University Hosptial — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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