Enterra Therapy Clinical Study (Gastric Stimulation for Gastroparesis)

February 23, 2010 updated by: MedtronicNeuro

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Reduction in Frequency of Weekly Vomiting Episodes When the Device is Turned ON, Relative to When the Device is Turned OFF
Time Frame: 4.5 months and 7.5 months
Diaries were used to record daily vomiting episodes for 28 days prior to each office follow-up visit. The weekly vomiting frequency (WVF) was based on the average number of weekly vomiting episodes recorded in the patient diary. The percent reduction is calculated as ((WVF during OFF - WVF during ON)/ (WVF during OFF))*100%. A positive reduction represents an improvement in WVF when the device was ON.
4.5 months and 7.5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Reduction in Symptom Score When the Device is Turned ON, Relative to When the Device is Turned OFF
Time Frame: 4.5 months and 7.5 months
A symptom interview was conducted at each visit to assess vomiting, nausea, early satiety, bloating, postprandial fullness, epigastric pain and epigastric burning. The scale for each symptom ranges from 0 to 4, with 0 being absence of symptoms and 4 being extremely frequent (≥ 7 episodes per week). Total symptom score (TSS) is the sum of the individual frequency symptom scores. The percent reduction is calculated as ((TSS during OFF - TSS during ON)/ (TSS during OFF))*100%. A positive reduction represents an improvement in TSS when the device was ON.
4.5 months and 7.5 months
Percent Reduction in the Frequency of Weekly Vomiting Episodes at 12 Months Compared to Baseline
Time Frame: baseline and 12 months
Diaries were used to record daily vomiting episodes for 28 days prior to each office follow-up visit. The weekly vomiting frequency (WVF) was based on the average number of weekly vomiting episodes recorded in the patient diary. The percent reduction is calculated as ((WVF at baseline - WVF at 12 months)/ (WVF at baseline))*100%. A positive reduction represents an improvement in WVF at 12 months.
baseline and 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Responders at 12 Months
Time Frame: baseline and 12 months
Responders were defined as having a 50% or greater reduction of WVF from baseline to 12 months. The percentage of responders was estimated as the proportion of the responders among all subjects who finished the 12-month visit. The percentage of responders was tested to determine if it was statistically greater than 50%.
baseline and 12 months
Change in Symptom Score at 12 Months Compared to Baseline.
Time Frame: baseline and 12 months
A symptom interview was conducted at each visit to assess vomiting, nausea, early satiety, bloating, postprandial fullness, epigastric pain and epigastric burning. The scale for each symptom ranges from 0 to 4, with 0 being absence of symptoms and 4 being extremely frequent (≥ 7 episodes per week). Total symptom score (TSS) is the sum of the individual frequency symptom scores. The change is calculated as TSS at baseline - TSS at 12 months. A positive change represents an improvement in TSS at 12 months.
baseline and 12 months
Change in Quality of Life (QOL) at 12 Months Compared to Baseline (Physical Component Summary)
Time Frame: baseline and 12 months
The QOL scores were collected using the SF-36 questionnaire, which included the scores in the following domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health. The raw score of 0 represents poor health and 100 represents best health. The physical component summary (PCS) score is a norm based score calculated from the raw scores of these 8 domains with a focus on physical health. The change in PCS is calculated as PCS at baseline - PCS at 12 months. A negative change in PCS represents an improvement in QOL.
baseline and 12 months
Change in Quality of Life at 12 Months Compared to Baseline (Mental Component Summary)
Time Frame: baseline and 12 months
The QOL scores were collected using the SF-36 questionnaire, which included the scores in the following domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health. The raw score of 0 represents poor health and 100 represents best health. The mental component summary (MCS) score is a norm based score calculated from the raw scores of these 8 domains with a focus on mental health. The change in MCS is calculated as MCS at baseline - MCS at 12 months. A negative change in MCS represents an improvement in QOL.
baseline and 12 months
Change in Gastric Emptying Results at 12 Months Compared to Baseline (2 Hours)
Time Frame: baseline and 12 months
Gastric emptying was evaluated using a standardized scintigraphy method and a low fat egg substitute test meal. After standard meal and marker preparation, the subsequent images were taken at 2 hours and 4 hours and percentage of gastric retention was evaluated. Change in 2-hour GET is calculated as % of gastric retention at 2 hours at baseline - % of gastric retention at 2 hours at 12 months. A positive change represents an improvement in gastric emptying at 12 months.
baseline and 12 months
Change in Gastric Emptying Results at 12 Months Compared to Baseline (4 Hours)
Time Frame: baseline and 12 months
Gastric emptying was evaluated using a standardized scintigraphy method and a low fat egg substitute test meal. After standard meal and marker preparation, the subsequent images were taken at 2 hours and 4 hours and percentage of gastric retention was evaluated. Change in 4-hour GET is calculated as % of gastric retention at 4 hours at baseline - % of gastric retention at 4 hours at 12 months. A positive change represents an improvement in gastric emptying at 12 months.
baseline and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MedtronicNeuro

Investigators

  • Study Director: Darin R Lerew, PhD, Medtronic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

March 10, 2010

Last Update Submitted That Met QC Criteria

February 23, 2010

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NDHF0025-70006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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