Verification of Needle Tip Placement in the Lumbar Epidural SpaceCOMPASSNCT02378727
CompuFlo® Assessment Study for the Epidural Space Verification
A study testing Active: Comparator Loss Of Resistance Syringe and Experimental: CompuFlo® Epidural System in people with Verification of Needle Tip Placement in the Lumbar Epidural Space, run by Milestone Scientific, Inc at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Verification of Needle Tip Placement in the Lumbar Epidural Space
- What is being tested?
- Active: Comparator Loss Of Resistance Syringe and Experimental: CompuFlo® Epidural System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2015to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Northwestern Memorial Hospital
Chicago, Illinois, 60611
University of Texas Houston
Houston, Texas, 77030
University of California Irvine
Irvine, California, 92697
Vitamed Research
Rancho Mirage, California, 92270
San Diego Pain Institute
San Diego, California, 92111
About this study
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
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.
- Being tested
- Active: Comparator Loss Of Resistance Syringe, Experimental: CompuFlo® Epidural System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active: Comparator Loss Of Resistance SyringeDevice
Lumbar epidural procedure utilizing Loss of Resistance Syringe
Experimental: CompuFlo® Epidural SystemDevice
CompuFlo® Epidural is intended for use with an epidural needle for the verification of needle tip placement in the lumbar epidural space
| Study group | Role | What they receive |
|---|---|---|
| A Standard Care Group (SCG) | Active comparator | Standard Care Conventional Group (SCG): 158 subjects to receive lumbar epidural procedure with the loss of resistance syringe used to identify the epidural space Receives: Device: Active: Comparator Loss Of Resistance Syringe |
| Experimental Procedure Group (EPG). | Experimental | 158 of subjects to receive lumbar epidural procedure with the CompuFlo® Epidural System used to identify the epidural space Receives: Device: Experimental: CompuFlo® Epidural System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness Objective (successful performance of lumbar epidural procedure)
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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startJan 2015
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Verification of Needle Tip Placement in the Lumbar Epidural SpaceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milestone Scientific, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ralf Gebhard, MD, Study chair, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02378727
- Sponsor's protocol ID
- EPI-INT14-01
- Acronym
- COMPASS
- Status last verified
- Jun 2016
- First submitted
- 23 Feb 2015
- Last updated
- 6 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02378727
- Acronym / sponsor ID
- COMPASS / EPI-INT14-01
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Milestone Scientific, IncIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 4 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A Standard Care Group (SCG) | Active comparator | Device: Active: Comparator Loss Of Resistance SyringeStandard Care Conventional Group (SCG): 158 subjects to receive lumbar epidural procedure with the loss of resistance syringe used to identify the epidural space |
| Experimental Procedure Group (EPG). | Experimental | Device: Experimental: CompuFlo® Epidural System158 of subjects to receive lumbar epidural procedure with the CompuFlo® Epidural System used to identify the epidural space |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active: Comparator Loss Of Resistance SyringeLumbar epidural procedure utilizing Loss of Resistance Syringe | Device | A Standard Care Group (SCG) |
| Experimental: CompuFlo® Epidural SystemCompuFlo® Epidural is intended for use with an epidural needle for the verification of needle tip placement in the lumbar epidural space | Device | Experimental Procedure Group (EPG). |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2016.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralf Gebhard, MD study chair
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
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active: Comparator Loss Of Resistance Syringe and Experimental: CompuFlo® Epidural System in people with Verification of Needle Tip Placement in the Lumbar Epidural Space, run by Milestone Scientific, Inc at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effectiveness Objective (successful performance of lumbar epidural procedure) (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2016.