- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00432835
Temporary Gastric Electrical Stimulation for Drug Refractory Gastroparesis
Double-Blind Placebo-Controlled Cross-Over Design With Wash-Out for Temporary Gastric Electrical Stimulation for Drug Refractory Gastroparesis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Mississippi
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Jackson, Mississippi, United States, 39216
- University of Mississippi Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: 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
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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 Names:
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Active Comparator: 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.
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symptom of Vomiting Associated With Gastroparesis
Time Frame: Study Day 0 (Baseline), Day 3, Day 7
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Likert Scale 0-4 (low-high) using a patient reported outcomes tool
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Study Day 0 (Baseline), Day 3, Day 7
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Symptom of Nausea Associated With Gastroparesis
Time Frame: Study Day 0 (Baseline), Day 3, Day 7
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Likert Scale 0-4 (low-high) using a patient reported outcomes tool
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Study Day 0 (Baseline), Day 3, Day 7
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Symptom of Gastric Emptying Time (GET) Associated With Gastroparesis
Time Frame: Study Day 0 (Baseline), Day 4, Day 8
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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.
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Study Day 0 (Baseline), Day 4, Day 8
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Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2004-0185
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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