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Neurostimulation for the Treatment of Post-Operative Ileus

NCT00854074 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-02-19

No results posted yet for this study

Summary

The primary goal of this study is to validate the design of the ElectroCore RMS-1100 Resolution Motility System™ and the ability to safely place a stimulation electrode in the epidural space of the spine in a post-operative subject, and to evaluate the subject's ability to tolerate stimulation for up to 48 hours. The secondary goal is to confirm that the electrical signal being delivered via this electrode shows evidence of effectiveness in improving the functional GI motility in subjects experiencing post-operative paralytic ileus

Conditions

  • Ileus

Interventions

DEVICE

ElectroCore RMS-1100 Resolution Motility System™

An electrical neurostimulation signal will be applied to the spine

Sponsors & Collaborators

  • ElectroCore INC

    lead INDUSTRY

Principal Investigators

  • Michael Erdeck, MD · Johns Hopkins Medical Center

  • David Walega, MD · Northwestern University Medical Center

  • Robert Frye, MD · Pennsylvania Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2009-12-31
Completion
2010-01-31

Countries

  • United States

Study Locations

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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 NCT00854074 on ClinicalTrials.gov