Overview

This trial is active, not recruiting.

Condition verification of needle tip placement in the lumbar epidural space
Treatments active: comparator loss of resistance syringe, experimental: compuflo® epidural system
Sponsor Milestone Scientific, Inc
Start date January 2015
End date July 2016
Trial size 400 participants
Trial identifier NCT02378727, EPI-INT14-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose diagnostic
Arm
(Active Comparator)
Standard Care Conventional Group (SCG): 158 subjects to receive lumbar epidural procedure with the loss of resistance syringe used to identify the epidural space
active: comparator loss of resistance syringe
Lumbar epidural procedure utilizing Loss of Resistance Syringe
(Experimental)
158 of subjects to receive lumbar epidural procedure with the CompuFlo® Epidural System used to identify the epidural space
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

Primary Outcomes

Measure
Primary Effectiveness Objective (successful performance of lumbar epidural procedure)
time frame: 1 week

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

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.

Additional Information

Official title CompuFlo® Assessment Study (COMPASS): A Randomized, Controlled, Parallel Group, Multicenter, Pivotal Study to Assess the Safety and Effectiveness of the Epidural Space Verification With the CompuFlo® Epidural Computer Controlled System
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Milestone Scientific, Inc.