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CompuFlo® Assessment Study for the Epidural Space Verification

NCT02378727 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2016-07-06

No results posted yet for this study

Summary

The purpose of this pivotal study is to demonstrate safety and effectiveness of the CompuFlo® Epidural Computer Controlled System (referred to hereafter as CompuFlo® Epidural) for the epidural space verification.

The CompuFlo® Epidural System is limited by federal law for investigational use only in United States of America and has received CE mark in European Union.

Conditions

  • Verification of Needle Tip Placement in the Lumbar Epidural Space

Interventions

DEVICE

Active: Comparator Loss Of Resistance Syringe

Lumbar epidural procedure utilizing Loss of Resistance Syringe

DEVICE

Experimental: CompuFlo® Epidural System

CompuFlo® Epidural is intended for use with an epidural needle for the verification of needle tip placement in the lumbar epidural space

Sponsors & Collaborators

  • Milestone Scientific, Inc

    lead INDUSTRY

Principal Investigators

  • Ralf Gebhard, MD · Professor of Anesthesiology Professor of Orthopedics and Rehabilitation Director, Division of Regional Anesthesia and Acute Perioperative Pain Management University of Miami-Miller School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
FACTORIAL

Eligibility

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

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-07-31
Completion
2016-07-31

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 NCT02378727 on ClinicalTrials.gov