CompuFlo® Assessment Study for the Epidural Space Verification (COMPASS)

Milestone Scientific

Status: Unknown

Conditions: Verification of Needle Tip Placement in the Lumbar Epidural Space

Treatments: Device: Active: Comparator Loss Of Resistance Syringe; Device: Experimental: CompuFlo® Epidural System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02378727

EPI-INT14-01

Details and patient eligibility

About

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.

Enrollment: 400 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

A Standard Care Group (SCG)

Active Comparator group

Description:

Standard Care Conventional Group (SCG): 158 subjects to receive lumbar epidural procedure with the loss of resistance syringe used to identify the epidural space

Treatment:

Device: Active: Comparator Loss Of Resistance Syringe

Experimental Procedure Group (EPG).

Experimental group

Description:

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

Treatment:

Device: Experimental: CompuFlo® Epidural System