Status:
COMPLETED
Temporary Gastric Electrical Stimulation for Drug Refractory Gastroparesis
Lead Sponsor:
University of Mississippi Medical Center
Collaborating Sponsors:
Medtronic
Conditions:
Gastroparesis
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
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...
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 sati...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00432835
Start Date
August 1 2005
End Date
November 1 2007
Last Update
December 3 2012
Active Locations (1)
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1
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216