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.
1. The Subject is at least 18 years of age at screening, but has not had their 91st
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
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.
Ralf Gebhard, MD
Professor of Anesthesiology Professor of Orthopedics and Rehabilitation Director, Division of Region
Sanja ILIC, MD, MS, RAC