CompuFlo® Assessment Study for the Epidural Space Verification

Conditions

• Verification of Needle Tip Placement in the Lumbar Epidural Space

Eligibility Criteria

Sex

ALL

Age

18 Years - 90 Years

Healthy Volunteers

Not accepted

Interventions

• Active: Comparator Loss Of Resistance Syringe — DEVICE
  Lumbar epidural procedure utilizing Loss of Resistance Syringe
• Experimental: CompuFlo® Epidural System — DEVICE
  CompuFlo® Epidural is intended for use with an epidural needle for the verification of needle tip placement in the lumbar epidural space

Study Details

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.

Key Dates

First listed

Mar 4, 2015

Start date

Jan 31, 2015

Status verified

Jun 2016

Primary completion

Jul 31, 2016

Completion

Jul 31, 2016

Study Design

Enrollment

400 participants (actual)

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

DIAGNOSTIC

Arms

• Active Comparator: A Standard Care Group (SCG)
  Standard Care Conventional Group (SCG): 158 subjects to receive lumbar epidural procedure with the loss of resistance syringe used to identify the epidural space
• Experimental: Experimental Procedure Group (EPG).
  158 of subjects to receive lumbar epidural procedure with the CompuFlo® Epidural System used to identify the epidural space

Primary Outcome Measure

Primary Effectiveness Objective (successful performance of lumbar epidural procedure) [ Time Frame: 1 week ]

Locations (5)

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