Cardiac Vagal Effects of GES in Patients With Gastroparesis and Vagal Nerve Action Potentials in Vagus Nerve



Status:Enrolling by invitation
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 90
Updated:10/27/2018
Start Date:November 2012
End Date:December 2020

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Trial Summary
Trial Overview
Inclusion Criteria

Cardiac Vagal Effects of Gastric Electrical Stimulation and Vagal Nerve Action Potentials in Vagus Nerve in Patients With Gastroparesis

The objective of this study is to determine if Gastric Electrical Stimulation may influence
vagal outflow via vagal afferent fibers that terminate in the Central Nervous System.

This study will evaluate male and female patients at least 18 years of age, with
gastroparesis, who will or have already undergone the implantation of a GES device

The study will be conducted at one center and approximately 200 subjects will be enrolled.

Subjects undergoing the GES implantation will be enrolled before the implantation and may
have a baseline visit. The visit procedures will be conducted at the discretion of the
investigator dependent on the clinical condition of the patient at that time.

Inclusion Criteria:

- At least 18 years of age.

- Documented diagnosis of gastroparesis.

- Will undergo implantation of a GES device or already has a GES device implanted

Exclusion Criteria:

- Pregnancy

- History of allergic reaction to EKG lead placement adhesives.

- unable to give informed consent
We found this trial at
1
site
Indiana University Hospital
550 University Boulevard
Indianapolis, Indiana 46202
?
mi
from
Indianapolis, IN
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