Enterra Therapy - Washington, DC

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Official Title of Trial

Gastric Stimulation for Vomiting, Nausea and Related Symptoms Associated with Gastroparesis Using Enterra Gastric Stimulation System

City and State

Washington, DC

Purpose of Trial

A research study to determine if an implanted device to stimulate the stomach will improve symptoms (such as nausea and vomiting) associated with gastroparesis (a disorder in which the stomach takes too long to empty its contents).

Condition

Gastroparesis

Treatment or Intervention

Enterra Therapy

Phase of Trial

Medical Device Trial

Sponsor

Medtronic, Inc.

Type of Study

Interventional

Study Design

Double-blind, randomized, cross-over study

Study Start Date

June 2002

Study Completion Date

To be determined

Eligibility

See inclusion/exclusion 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

Location

The Medical Faculty Associates
The George Washington University
2150 Pennsylvania Ave., 6B
Washington, DC 20037

Trial Contact Information

Elizabeth Drenon
Phone: 202-741-3168
E-mail: edrenon@mfa.gwu.edu

Principal Investigator(s)

Fredrick Brody, MD