NCT00157755

Enterra Therapy Clinical Study (Gastric Stimulation for Gastroparesis)

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: MedtronicNeuro · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastroparesis

Interventions

Type	Name	Description
DEVICE	Enterra Therapy	Gastric electrical stimulation using Enterra Therapy.

Timeline

• Start date: 2002-06-01
• Primary completion: 2008-12-01
• Completion: 2009-03-01
• First posted: 2005-09-12
• Last updated: 2010-03-10
• Results posted: 2010-03-10

Locations

6 sites across 1 country: United States