CompuFlo® Assessment Study for the Epidural Space Verification

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Verification of Needle Tip Placement in the Lumbar Epidural Space

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Active: Comparator Loss Of Resistance Syringe

Intervention Type DEVICE

Lumbar epidural procedure utilizing Loss of Resistance Syringe

Experimental Procedure Group (EPG).

158 of subjects to receive lumbar epidural procedure with the CompuFlo® Epidural System used to identify the epidural space

Group Type EXPERIMENTAL

Experimental: CompuFlo® Epidural System

Intervention Type DEVICE

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

Interventions

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Active: Comparator Loss Of Resistance Syringe

Lumbar epidural procedure utilizing Loss of Resistance Syringe

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. The Subject is at least 18 years of age at screening, but has not had their 91st birthday.
2. The Subject is required to have epidural procedure implemented as part of their standard medical treatment according to Principal Investigator assessment.
3. The Subject is willing to undergo the Informed Consent process prior to enrollment into this study.
4. The Subject is willing to participate in this study for at least 30 days after the epidural procedure implementation.
5. The Subject is willing to participate in this study for at least 3 days after the procedure.

Exclusion Criteria

1. Contraindications for epidural procedure / anesthesia (circumstances where the risks associated with epidural procedures are higher than usual. These circumstances include, but are not limited to anatomical abnormalities, such as spina bifida or scoliosis, infection at or near the site of insertion, allergy to the anesthetic or intended drug, uncorrected hypovolemia, increased intracranial pressure etc.).
2. Patients presenting for emergency c-section or other emergencies.
3. Exclusive use of other treatments such as intravenous analgesia with opioids.
4. Prior back surgery in lumbar area that would prevent epidural access.
5. Preexisting neurological deficit that would interfere with dermatome identification.
6. The Subject observed seizure within 7 days prior to study enrollment.
7. Presumed and/or confirmed septic embolus.
8. The Subject has a skin condition (i.e., hemangioma, scleroderma, psoriasis, rash, open wound or tattoo) in their lumbar region greater than 4 cm2.
9. The Subject previously participated in another investigational drug or device trial within the preceding 4 weeks.
10. Severe co-existing or terminal systemic disease that limits life expectancy or may interfere with study procedures.
11. The Subject is otherwise determined by the Investigator to be medically unsuitable for participation in this study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ralf Gebhard, MD

Role: STUDY_CHAIR

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