Back to resultsEnterra Therapy Clinical Study (Gastric Stimulation for Gastroparesis)
Primary Purpose
Gastroparesis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enterra Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Gastroparesis focused on measuring Nausea and Vomiting
Eligibility 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
Sites / Locations
- Contact Medtronic for exact location
- Contact Medtronic for exact location
- Contact Medtronic for exact location
- Contact Medtronic for exact location
- Contact Medtronic for exact location
- Contact Medtronic for exact location
Outcomes
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
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00157755
Brief Title
Enterra Therapy Clinical Study (Gastric Stimulation for Gastroparesis)
Official Title
Gastric Stimulation for Vomiting, Nausea and Related Symptoms Associated With Gastroparesis Using Enterra® Gastric Stimulation System
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Terminated
Study Start Date
June 2002 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
MedtronicNeuro
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroparesis
Keywords
Nausea and Vomiting
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Enterra Therapy
Intervention Description
Gastric electrical stimulation using Enterra Therapy.
Primary Outcome Measure Information:
Title
Percent Reduction in Frequency of Weekly Vomiting Episodes When the Device is Turned ON, Relative to When the Device is Turned OFF
Description
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.
Time Frame
4.5 months and 7.5 months
Secondary Outcome Measure Information:
Title
Percent Reduction in Symptom Score When the Device is Turned ON, Relative to When the Device is Turned OFF
Description
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.
Time Frame
4.5 months and 7.5 months
Title
Percent Reduction in the Frequency of Weekly Vomiting Episodes at 12 Months Compared to Baseline
Description
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.
Time Frame
baseline and 12 months
Other Pre-specified Outcome Measures:
Title
Percentage of Responders at 12 Months
Description
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%.
Time Frame
baseline and 12 months
Title
Change in Symptom Score at 12 Months Compared to Baseline.
Description
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.
Time Frame
baseline and 12 months
Title
Change in Quality of Life (QOL) at 12 Months Compared to Baseline (Physical Component Summary)
Description
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.
Time Frame
baseline and 12 months
Title
Change in Quality of Life at 12 Months Compared to Baseline (Mental Component Summary)
Description
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.
Time Frame
baseline and 12 months
Title
Change in Gastric Emptying Results at 12 Months Compared to Baseline (2 Hours)
Description
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.
Time Frame
baseline and 12 months
Title
Change in Gastric Emptying Results at 12 Months Compared to Baseline (4 Hours)
Description
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.
Time Frame
baseline and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darin R Lerew, PhD
Organizational Affiliation
Medtronic
Official's Role
Study Director
Facility Information:
Facility Name
Contact Medtronic for exact location
City
San Francisco
State/Province
California
Country
United States
Facility Name
Contact Medtronic for exact location
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
Contact Medtronic for exact location
City
Anderson
State/Province
Indiana
Country
United States
Facility Name
Contact Medtronic for exact location
City
Kansas City
State/Province
Kansas
Country
United States
Facility Name
Contact Medtronic for exact location
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
Contact Medtronic for exact location
City
Philadelphia
State/Province
Pennsylvania
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20538073
Citation
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.
Results Reference
derived
Learn more about this trial
Enterra Therapy Clinical Study (Gastric Stimulation for Gastroparesis)
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