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Status unknownNCT02378727COMPASSUpdated Jul 6, 2016

CompuFlo® Assessment Study for the Epidural Space Verification

An interventional study of Active: Comparator Loss Of Resistance Syringe and Experimental: CompuFlo® Epidural System in Verification of Needle Tip Placement in the Lumbar Epidural Space, sponsored by Milestone Scientific, Inc. Status unknown at 5 sites in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2016-07-06.

Sponsored by Milestone Scientific, Inc · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jun 2016), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

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Conditions studied

  • Verification of Needle Tip Placement in the Lumbar Epidural Space
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In context

Lead sponsor

This is the only study on the registry with Milestone Scientific, Inc as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
400 participants (actual)

Study arms

  • 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

    Device: Active: Comparator 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

    Device: Experimental: CompuFlo® Epidural System

Interventions

  • DeviceActive: Comparator Loss Of Resistance Syringe

    Lumbar epidural procedure utilizing Loss of Resistance Syringe

  • DeviceExperimental: CompuFlo® Epidural System

    CompuFlo® Epidural is intended for use with an epidural needle for the verification of needle tip placement in the lumbar epidural space

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 week

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Study locations

5 sites
  • University of California Irvine
    Irvine, California 92697, United States
  • Vitamed Research
    Rancho Mirage, California 92270, United States
  • San Diego Pain Institute
    San Diego, California 92111, United States
  • Northwestern Memorial Hospital
    Chicago, Illinois 60611, United States
  • University of Texas Houston
    Houston, Texas 77030, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02378727
Lead sponsor
Milestone Scientific, Inc
Responsible party
Sponsor
First posted
Mar 4, 2015
Start date
Jan 2015
Primary completion
Jul 2016 (estimated)
Completion
Jul 2016 (estimated)
Last update
Jul 6, 2016

Study contacts

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

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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