CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 58 enrolled
Drug / intervention
Gastric Electrical Stimulator, Enterra, Medtronics, Inc.device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00432835
NCT00432835Phase 3Completed
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Double-Blind Placebo-Controlled Cross-Over Design With Wash-Out for Temporary Gastric Electrical Stimulation for Drug Refractory Gastroparesis

University of Mississippi Medical Center·interventional·Posted Feb 8, 2007·Updated Dec 3, 2012

In Brief

A Phase 3 clinical trial evaluating Gastric Electrical Stimulator, Enterra, Medtronics, Inc. for Gastroparesis. Completed, enrolled 58 participants across 1 site.

Detailed Summary

The purpose of this research is to determine if temporary gastric electrical stimulation will help improve symptoms of gastroparesis (abnormal stomach emptying). We hypothesize that when the device is ON, Gastrointestinal symptoms will decrease by at least 50% from baseline.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastroparesis
CountriesUnited States
CollaboratorsMedtronic

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 8, 2007
Enrollment StartAug 1, 2005
Primary CompletionOct 1, 2006
Study CompletionNov 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 19.4 years ago

Interventions

Gastric Electrical Stimulator, Enterra, Medtronics, Inc.device

All patients received a GES electrode, endoscopically placed and connected to an external device at baseline. The device was turned ON to provide 72 continuous hours of active stimulation and OFF to deactivate stimulation