Status:
TERMINATED
Enterra Therapy Clinical Study (Gastric Stimulation for Gastroparesis)
Lead Sponsor:
MedtronicNeuro
Conditions:
Gastroparesis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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. There are tw...
Eligibility Criteria
Inclusion
- Male or Female at least 18 years of age
- Diagnosed with gastroparesis due to diabetes or an unknown cause (idiopathic)
- Have tried prokinetic (help the stomach empty quicker) and antiemetic (help decrease symptoms of nausea and vomiting) medications for a minimum of one month, unless you're unable to take these types of medications
- Have symptoms of gastroparesis that have required treatment for at least one year
- Experience at least 7 episodes of vomiting during a seven consecutive day period on a 28-day diary
- Willing and able to completely and accurately fill out a diary and questionnaires throughout the study
- Have gastric retention of greater than 10% at four hours, or greater than 60% at two hours (if unable to complete the four-hour test) on a Gastric Emptying Test (GET)
Exclusion
- Gastroparesis caused by a specific diagnosed illness other than diabetes
- Current eating disorder or diagnosed swallowing disorder
- Previous stomach surgeries
- Taking narcotic pain-relievers daily for abdominal pain
- Diagnosed with drug or alcohol dependency within 1 year before the study
- Life expectancy less than one year
- Have other implantable devices such as pacemakers
- Pregnancy or planned pregnancy
- Plan to receive diathermy treatment
- Have had radiation therapy of the upper abdomen
- Plan on having an MRI performed
- Currently participating in another investigational device or drug study
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT00157755
Start Date
June 1 2002
End Date
March 1 2009
Last Update
March 10 2010
Active Locations (6)
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1
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San Francisco, California, United States
2
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Washington D.C., District of Columbia, United States
3
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Anderson, Indiana, United States
4
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Kansas City, Kansas, United States