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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for not_applicable

Timeline

Completed

Started Jun 2002

Longer than P75 for not_applicable

Geographic Reach

1 country

6 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6.8 years study duration

Study Start

First participant enrolled

June 1, 2002

Completed

3.3 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed

4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed

3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed

1 year until next milestone

Results Posted

Study results publicly available

March 10, 2010

Completed

Last Updated

March 10, 2010

Status Verified

December 1, 2009

Enrollment Period

6.5 years

First QC Date

September 8, 2005

Results QC Date

December 18, 2009

Last Update Submit

February 23, 2010

Conditions

Gastroparesis

Keywords

Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

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 Outcomes (2)

Percent Reduction in Symptom Score When the Device is Turned ON, Relative to When the Device is Turned OFF
4.5 months and 7.5 months
Percent Reduction in the Frequency of Weekly Vomiting Episodes at 12 Months Compared to Baseline
baseline and 12 months

Other Outcomes (6)

Percentage of Responders at 12 Months
baseline and 12 months
Change in Symptom Score at 12 Months Compared to Baseline.
baseline and 12 months
Change in Quality of Life (QOL) at 12 Months Compared to Baseline (Physical Component Summary)
baseline and 12 months
+3 more other outcomes

Interventions

Enterra TherapyDEVICE

Gastric electrical stimulation using Enterra Therapy.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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)

You may not qualify if:

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

Contact the study team to confirm eligibility.