Clinical trial NCT00157755: 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
Overall status: TERMINATED
Phase: NA
Conditions: Gastroparesis
Keywords: Nausea and Vomiting
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percent Reduction in Frequency of Weekly Vomiting Episodes When the Device is Turned ON, Relative to When the Device is Turned OFF
timeFrame: 4.5 months and 7.5 months
Secondary outcomes:
measure: Percent Reduction in Symptom Score When the Device is Turned ON, Relative to When the Device is Turned OFF
timeFrame: 4.5 months and 7.5 months
measure: Percent Reduction in the Frequency of Weekly Vomiting Episodes at 12 Months Compared to Baseline
timeFrame: baseline and 12 months
Other outcomes:
measure: Percentage of Responders at 12 Months
timeFrame: baseline and 12 months
measure: Change in Symptom Score at 12 Months Compared to Baseline.
timeFrame: baseline and 12 months
measure: Change in Quality of Life (QOL) at 12 Months Compared to Baseline (Physical Component Summary)
timeFrame: baseline and 12 months
measure: Change in Quality of Life at 12 Months Compared to Baseline (Mental Component Summary)
timeFrame: baseline and 12 months
measure: Change in Gastric Emptying Results at 12 Months Compared to Baseline (2 Hours)
timeFrame: baseline and 12 months
measure: Change in Gastric Emptying Results at 12 Months Compared to Baseline (4 Hours)
timeFrame: baseline and 12 months
Locations:
city: San Francisco
country: United States
facility: Contact Medtronic for exact location
state: California
city: Washington
country: United States
facility: Contact Medtronic for exact location
state: District of Columbia
city: Anderson
country: United States
facility: Contact Medtronic for exact location
state: Indiana
city: Kansas City
country: United States
facility: Contact Medtronic for exact location
state: Kansas
city: Louisville
country: United States
facility: Contact Medtronic for exact location
state: Kentucky
city: Philadelphia
country: United States
facility: Contact Medtronic for exact location
state: Pennsylvania
Study officials:
affiliation: Medtronic
name: Darin R Lerew, PhD
role: STUDY_DIRECTOR
References:
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.