CompuFlo® Assessment Study for the Epidural Space Verification

Status unconfirmed · Not applicable

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

In brief

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 facts

Study ID

NCT02378727

Run by

Milestone Scientific, Inc

People needed

400

Starts

2015-01-01

Expected to finish

2016-07-01

Last updated by the study team

2016-07-06

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.).
• Patients presenting for emergency c-section or other emergencies.
• Exclusive use of other treatments such as intravenous analgesia with opioids.
• Prior back surgery in lumbar area that would prevent epidural access.
• Preexisting neurological deficit that would interfere with dermatome identification.
• The Subject observed seizure within 7 days prior to study enrollment.
• Presumed and/or confirmed septic embolus.
• The Subject has a skin condition (i.e., hemangioma, scleroderma, psoriasis, rash, open wound or tattoo) in their lumbar region greater than 4 cm2.
• The Subject previously participated in another investigational drug or device trial within the preceding 4 weeks.
• Severe co-existing or terminal systemic disease that limits life expectancy or may interfere with study procedures.
• The Subject is otherwise determined by the Investigator to be medically unsuitable for participation in this study.

Where it is running

• University of California Irvine — Irvine, California, United States
• Vitamed Research — Rancho Mirage, California, United States
• San Diego Pain Institute — San Diego, California, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• University of Texas Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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