Temporary Gastric Electrical Stimulation for Drug Refractory Gastroparesis
NCT ID: NCT00432835
Last Updated: 2012-12-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
58 participants
INTERVENTIONAL
2005-08-31
2007-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Gastric Stimulation Days1-4/Sham5-8
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
Gastric Electrical Stimulator, Enterra, Medtronics, Inc.
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
Sham1-4/Gastric Stimulation Days5-8
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.
Gastric Electrical Stimulator, Enterra, Medtronics, Inc.
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
Interventions
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Gastric Electrical Stimulator, Enterra, Medtronics, Inc.
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
70 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
University of Mississippi Medical Center
OTHER
Responsible Party
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Thomas Abell, MD
Principal Investigator, Professor of Medicine, Director, Division of Digestive Diseases
Principal Investigators
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Thomas L Abell, MD
Role: PRINCIPAL_INVESTIGATOR
University of Mississippi Medical Center
Locations
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University of Mississippi Medical Center
Jackson, Mississippi, United States
Countries
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References
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Abell TL, Johnson WD, Kedar A, Runnels JM, Thompson J, Weeks ES, Minocha A, Griswold ME. A double-masked, randomized, placebo-controlled trial of temporary endoscopic mucosal gastric electrical stimulation for gastroparesis. Gastrointest Endosc. 2011 Sep;74(3):496-503.e3. doi: 10.1016/j.gie.2011.05.022.
Related Links
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Pub Med abstract of study as reported in "Gastrointestinal Endoscopy"
Other Identifiers
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2004-0185
Identifier Type: -
Identifier Source: org_study_id