Enterra Therapy Clinical Study (Gastric Stimulation for Gastroparesis) - Full Text View

Sponsored by:	MedtronicNeuro
Information provided by:	MedtronicNeuro
ClinicalTrials.gov Identifier:	NCT00157755

Purpose

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 arms of 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.

Condition	Intervention
Gastroparesis	Device: Enterra Therapy

MedlinePlus related topics: Nausea and Vomiting

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Gastric Stimulation for Vomiting, Nausea and Related Symptoms Associated With Gastroparesis Using Enterra® Gastric Stimulation System

Further study details as provided by MedtronicNeuro:

Primary Outcome Measures:

Reduction in frequency of weekly vomiting episodes when the device is turned ON, relative to when the device is turned OFF [ Time Frame: 7.5 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Reduction in symptom score when the device is turned ON, relative to when the device is turned OFF [ Time Frame: 7.5 months ] [ Designated as safety issue: No ]
Long-term reduction in the frequency of weekly vomiting episodes [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment:	87
Study Start Date:	June 2002
Estimated Study Completion Date:	March 2009
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Gastric electrical stimulation using Enterra Therapy.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00157755

Locations

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

Sponsors and Collaborators

MedtronicNeuro

Investigators

Study Director:

Darin R Lerew, PhD

Medtronic

More Information

No publications provided

Responsible Party:	Medtronic Neuromodulation ( Darin Lerew, Sr. Clinical Manager )
Study ID Numbers:	NDHF0025-70006
Study First Received:	September 8, 2005
Last Updated:	February 23, 2009
ClinicalTrials.gov Identifier:	NCT00157755 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by MedtronicNeuro:

Nausea and Vomiting

Study placed in the following topic categories:

Paralysis
Signs and Symptoms
Digestive System Diseases
Stomach Diseases
Vomiting

Gastrointestinal Diseases
Neurologic Manifestations
Nausea
Gastroparesis

Additional relevant MeSH terms:

Paralysis
Signs and Symptoms
Digestive System Diseases
Stomach Diseases

Gastrointestinal Diseases
Neurologic Manifestations
Gastroparesis

ClinicalTrials.gov processed this record on May 06, 2009