Escalating Temporary Gastric Electrical Stimulation (GES) for Severe Gastroparesis

Indiana University19 enrolled

Overview

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),

Study Type

OBSERVATIONAL

Enrollment

Conditions

Gastroparesis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Indiana University Hosptial

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

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

Time frame: 1 month

Secondary Outcomes

Clinical response to t-GES placement as measured by questionnaires

Measuring the responses to questionnaires before and after placement of GES

Time frame: 1 year

Develop a prospective registry in patients undergoing escalating t-GES

Have a database of patients undergoing t-GES placement

Time frame: 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

Time frame: 1 year

Data from ClinicalTrials.gov

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