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The purpose of this research is to determine if temporary gastric electrical stimulation will help improve symptoms of gastroparesis (abnormal stomach emptying). We hypothesize that when the device is ON, GI symptoms will decrease by at least 50% from baseline.
Gastric Electrical Stimulation (GES) is an established treatment for drug-refractory patients who have the symptoms of gastroparesis/gastropathy (GP). The symptoms of GP are nausea, vomiting, anorexia/early satiety, bloating/distention and abdominal pain and are classically associated with delayed gastric emptying of solids. The technique of GES was first used, in a patient seen at UT-Memphis in 1993 and has undergone several clinical trials, particularly the GEMS trial, a feasibility trial starting in 1995 and the WAVESS trial, a double-blind trial begun in 1997. Both were international trials, showing promising results, and both have been published in the last 2 years. However, a number of issues related to who would benefit the most from GES therapy have emerged. Among these issues are whether patients with etiologies other than diabetic or idiopathic gastroparesis, such as post-surgical gastropathy, which is often related to rapid, not delayed gastric emptying could be helped.
Most recently a technique for the temporary placement of a GES electrode in the stomach with an upper endoscope, combined with an external GES device, has been tried and validated, first at UAMS in Little Rock, AR, beginning in 2001 and more recently here at UMMC, beginning later in 2001 and up until the present time. Using the technique of temporary gastric electrical stimulation (TempStim), we have been able to demonstrate that TempStim can quickly demonstrate (in a manner of days) that a patient will respond to temporary GES, as quantified by a decrease in GI total symptoms and an improvement and normalization in solid gastric emptying.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Gastric Electrical Stimulator
University of Mississippi Medical Center
Active, not recruiting
University of Mississippi Medical Center
Published on BioPortfolio: 2014-08-26T22:40:13-0400
This study is to evaluate the safety and effectiveness of gastric stimulation in the reduction of nausea and vomiting in patients with gastroparesis using an approved Humanitarian device. ...
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