Enterra Therapy Clinical Study (Gastric Stimulation for Gastroparesis)

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2009-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Gastroparesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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Enterra Therapy

Gastric electrical stimulation using Enterra Therapy.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No