Enterra Therapy Clinical Study (Gastric Stimulation for Gastroparesis)

Status Terminated

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.

Clinical Trial Description

n/a

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

Clinical Trial Details

NCT number	NCT00157755
Study type	Interventional
Source	MedtronicNeuro
Contact
Status	Terminated
Phase	N/A
Start date	June 2002
Completion date	March 2009

View Details

See also
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Withdrawn	`NCT02420925` - Effect of Celiac Plexus Block on Gastric Emptying and Symptoms Caused by Gastroparesis	N/A
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Terminated	`NCT00760461` - Domperidone in Refractory Gastroparesis	Phase 2