- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02378727
CompuFlo® Assessment Study for the Epidural Space Verification (COMPASS)
July 1, 2016 updated by: Milestone Scientific, Inc
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
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.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
400
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
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Irvine, California, United States, 92697
- University of California Irvine
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Rancho Mirage, California, United States, 92270
- Vitamed Research
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San Diego, California, United States, 92111
- San Diego Pain Institute
-
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern Memorial Hospital
-
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Texas
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Houston, Texas, United States, 77030
- University of Texas Houston
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: A Standard Care Group (SCG)
Standard Care Conventional Group (SCG): 158 subjects to receive lumbar epidural procedure with the loss of resistance syringe used to identify the epidural space
|
Lumbar epidural procedure utilizing Loss of Resistance Syringe
|
Experimental: Experimental Procedure Group (EPG).
158 of subjects to receive lumbar epidural procedure with the CompuFlo® Epidural System used to identify the epidural space
|
CompuFlo® Epidural is intended for use with an epidural needle for the verification of needle tip placement in the lumbar epidural space
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary Effectiveness Objective (successful performance of lumbar epidural procedure)
Time Frame: 1 week
|
Primary study endpoint is successful performance of lumbar epidural procedure indicated by loss to temperature sensation bilateral either 1) (i) in at least one dermatome for the non-labor procedures procedures or (ii) in at least two dermatomes for women in labor two dermatomes*, based on a maximum of 3 attempts at epidural space identificationor 2) by correct spread of dye in the epidural space as observed by fluoroscopy for those patients for whom fluoroscopy is performed as a standard medical procedure to identify the exact spine level (landmarking) along with confirmatory contrast dye, based on a maximum of 3 attempts at epidural space identification This is a binary categorical (yes/no) endpoint.
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Ralf Gebhard, MD, 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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2015
Primary Completion (Anticipated)
July 1, 2016
Study Completion (Anticipated)
July 1, 2016
Study Registration Dates
First Submitted
February 23, 2015
First Submitted That Met QC Criteria
March 3, 2015
First Posted (Estimate)
March 4, 2015
Study Record Updates
Last Update Posted (Estimate)
July 6, 2016
Last Update Submitted That Met QC Criteria
July 1, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- EPI-INT14-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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