Escalating Temporary Gastric Electrical Stimulation (GES) for Severe Gastroparesis

NCT ID: NCT02164591

Last Updated: 2020-08-04

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 19 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2019-01-31

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),

Conditions

Gastroparesis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

John M. Wo

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John M Wo, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Indiana University Hosptial

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

Temp GES

Identifier Type: -

Identifier Source: org_study_id