Enterra Therapy Clinical Study (Gastric Stimulation for Gastroparesis)

Gastroparesis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00157755
• Other study ID #: NDHF0025-70006
• Status: Terminated
• Phase: N/A
• First received: September 8, 2005
• Last updated: February 23, 2010
• Start date: June 2002
• Est. completion date: March 2009

Study information

• Verified date: December 2009
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 87
• Est. completion date: March 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroparesis

Intervention

Device:
• Enterra Therapy
Gastric electrical stimulation using Enterra Therapy.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No