Temporary Gastric Electrical Stimulation for Drug Refractory Gastroparesis

Study Overview
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Brief Summary
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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, Gastrointestinal symptoms will decrease by at least 50% from baseline.

Detailed Description
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Gastric Electrical Stimulation is an established treatment for drug-refractory patients who have the symptoms of gastroparesis/gastropathy. 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 University of Tennesse-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 Gastric Electrical Stimulation 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 Gastric Electrical Stimulation electrode in the stomach with an upper endoscope, combined with an external Gastric Electrical Stimulation 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, 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.

Official Title
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Double-Blind Placebo-Controlled Cross-Over Design With Wash-Out for Temporary Gastric Electrical Stimulation for Drug Refractory Gastroparesis

Conditions
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Gastroparesis

Intervention / Treatment
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* Device: Gastric Electrical Stimulator, Enterra, Medtronics, Inc.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sex: Male of Female Age Range: 18 to 70 inclusive Patients with GP of diabetic, surgically related or idiopathic etiology. Symptoms of GP for >/= 1 year. Refractory or intolerant to antiemetic drug classes (antihistamines and phenothiazines, serotonin receptor antagonists, dopamine receptor antagonists) Chronic vomiting and/or nausea with 7 or more episodes per week for either symptom irrespective of GET values. The patient is willing and able to provide informed consent. The patient is willing and able to return for required follow-up visits. Exclusion Criteria: Patients < 18 or >70 years in age. Patients with an active infection of any kind. Patients who the investigator determines are not candidates for endoscopic procedures. Women who are pregnant Inability or unwillingness to provide informed consent Unwilling or unable to return for required follow-up visits and examinations. Patients who are currently enrolled in another investigation of a medical device or drug.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gastric Stimulation Days1-4/Sham5-8<br>The sequence followed for patients in Group 1 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal EGG, then randomization to Group 1, then active stimulation for 72 consecutive hours, then a 1 day wash out, then the cross over, which entailed the device remaining inactive for the final 3 study days | Device: Gastric Electrical Stimulator, Enterra, Medtronics, Inc.<br>* All patients received a GES electrode, endoscopically placed and connected to an external device at baseline. The device was turned ON to provide 72 continuous hours of active stimulation and OFF to deactivate stimulation<br>* Other names: No other name currently exists.;|
| Active Comparator: Sham1-4/Gastric Stimulation Days5-8<br>The sequence followed for patients in Group 2 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal EGG, then randomization to Group 2, then no stimulation whatsoever until Day 5, then the cross over,then active stimulation with the Gastric Electrical Stimulator for 72 consecutive hours. | Device: Gastric Electrical Stimulator, Enterra, Medtronics, Inc.<br>* All patients received a GES electrode, endoscopically placed and connected to an external device at baseline. The device was turned ON to provide 72 continuous hours of active stimulation and OFF to deactivate stimulation<br>* Other names: No other name currently exists.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom of Vomiting Associated With Gastroparesis | Likert Scale 0-4 (low-high) using a patient reported outcomes tool | Study Day 0 (Baseline), Day 3, Day 7 | 
| Symptom of Nausea Associated With Gastroparesis | Likert Scale 0-4 (low-high) using a patient reported outcomes tool | Study Day 0 (Baseline), Day 3, Day 7 | 
| Symptom of Gastric Emptying Time (GET) Associated With Gastroparesis | Transit time of a radio-labeled meal through the stomach, measured by scintigraphy for %contents remaining in the stomach at 1 hour, 2 hours, and 4 hours. GET measures were obtained at baseline, during the period allowed for 'washout', and on the final study day. | Study Day 0 (Baseline), Day 4, Day 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nausea, Vomiting, Delayed gastric emptying, Diabetes Mellitus, Post-Surgical, Idiopathic