Enterra Therapy Clinical Study (Gastric Stimulation for Gastroparesis)

This study has been terminated.
Sponsor:
Information provided by:
MedtronicNeuro
ClinicalTrials.gov Identifier:
NCT00157755
First received: September 8, 2005
Last updated: February 23, 2010
Last verified: December 2009
  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 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.


Condition Intervention
Gastroparesis
Device: Enterra Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Gastric Stimulation for Vomiting, Nausea and Related Symptoms Associated With Gastroparesis Using Enterra® Gastric Stimulation System

Resource links provided by NLM:


Further study details as provided by MedtronicNeuro:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • Percent Reduction in the Frequency of Weekly Vomiting Episodes at 12 Months Compared to Baseline [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 87
Study Start Date: June 2002
Study Completion Date: March 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Enterra Therapy
    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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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
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Philadelphia, Pennsylvania, United States
Sponsors and Collaborators
MedtronicNeuro
Investigators
Study Director: Darin R Lerew, PhD Medtronic
  More Information

No publications provided by MedtronicNeuro

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Darin Lerew, Sr. Clinical Manager, Medtronic Neuromodulation
ClinicalTrials.gov Identifier: NCT00157755     History of Changes
Other Study ID Numbers: NDHF0025-70006
Study First Received: September 8, 2005
Results First Received: December 18, 2009
Last Updated: February 23, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by MedtronicNeuro:
Nausea and Vomiting

Additional relevant MeSH terms:
Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 20, 2014