Clinical trial NCT02378727: CompuFlo® Assessment Study for the Epidural Space Verification
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Verification of Needle Tip Placement in the Lumbar Epidural Space
Lead sponsor: Milestone Scientific, Inc
Sponsor class: INDUSTRY
First posted: 2015-03-04
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Primary Effectiveness Objective (successful performance of lumbar epidural procedure)
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California Irvine
state: California
city: Rancho Mirage
country: United States
facility: Vitamed Research
state: California
city: San Diego
country: United States
facility: San Diego Pain Institute
state: California
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Houston
country: United States
facility: University of Texas Houston
state: Texas
Study officials:
affiliation: 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
name: Ralf Gebhard, MD
role: STUDY_CHAIR
References: