Enterra Therapy Clinical Study (Gastric Stimulation for Gastroparesis)

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: Gastroparesis
• Intervention / Treatment: Device: Enterra Therapy

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

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

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

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	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	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	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	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.	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)	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)	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)	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)	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

• Sponsor: MedtronicNeuro
• Investigators: Study Director: Darin R Lerew, PhD, Medtronic

Publications and helpful links

General Publications

• McCallum RW, Snape W, Brody F, Wo J, Parkman HP, Nowak T. Gastric electrical stimulation with Enterra therapy improves symptoms from diabetic gastroparesis in a prospective study. Clin Gastroenterol Hepatol. 2010 Nov;8(11):947-54; quiz e116. doi: 10.1016/j.cgh.2010.05.020. Epub 2010 Jun 9.

Study record dates

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: Nausea and Vomiting
• Additional Relevant MeSH Terms: Digestive System Diseases; Neurologic Manifestations; Gastrointestinal Diseases; Stomach Diseases; Paralysis; Gastroparesis
• Other Study ID Numbers: NDHF0025-70006