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Escalating Temporary Gastric Electrical Stimulation (GES) for Severe Gastroparesis

Terminated
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
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
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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
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
Clinical response to t-GES placement as measured by questionnaires1 year

Measuring the responses to questionnaires before and after placement of GES

determine the feasibility and patient tolerability of endoscopic placement of t-GES1 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-GES1 year

Have a database of patients undergoing t-GES placement

Trial Locations

Locations (1)

Indiana University Hosptial

🇺🇸

Indianapolis, Indiana, United States

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