Enterra Therapy Clinical Study (Gastric Stimulation for Gastroparesis)

Stopped early · Not applicable

Conditions studied: Gastroparesis

In brief

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 two cohorts in this study based on etiology, one for diabetic and one for idiopathic. A maximum of 150 patients (75 diabetic and 75 idiopathic) from up to 15 centers in the United States will be followed closely for twelve months and then once a year after that until the study closes. If you are someone suffering with symptoms of gastroparesis despite trying oral medications, you may be eligible to participate in a clinical study using a surgically implanted gastric stimulator.

Key facts

Study ID

NCT00157755

Run by

MedtronicNeuro

People needed

87

Starts

2002-06-01

Expected to finish

2009-03-01

Last updated by the study team

2010-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Contact Medtronic for exact location — San Francisco, California, United States
• Contact Medtronic for exact location — Washington D.C., District of Columbia, United States
• Contact Medtronic for exact location — Anderson, Indiana, United States
• Contact Medtronic for exact location — Kansas City, Kansas, United States
• Contact Medtronic for exact location — Louisville, Kentucky, United States
• Contact Medtronic for exact location — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.