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Temporary Gastric Electrical Stimulation for Drug Refractory Gastroparesis

NCT00432835 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2012-12-03

Study results available
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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.

Conditions

Interventions

DEVICE

Gastric Electrical Stimulator, Enterra, Medtronics, Inc.

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

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • University of Mississippi Medical Center

    lead OTHER

Principal Investigators

  • Thomas L Abell, MD · University of Mississippi Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2006-10-31
Completion
2007-11-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00432835 on ClinicalTrials.gov