Handheld 3D Lumbar Spine Navigation: A Clinical Validation Study RM002

March 9, 2022 updated by: Mohamed Tiouririne, MD, University of Virginia

Currently, at UVA, handheld ultrasound devices (like those used to view an unborn baby) are only two dimensional. The Accuro is a three dimensional handheld ultrasound device. This device uses sound waves to create pictures of the spine in three dimensions. This may allow the physician to view the spine in more detail for procedures such as spinal anesthesia and other diagnostic procedures. Epidural analgesia is the mainstay procedure for the management of labor pain. The precise placement of a needle or catheter in proximity to landmarks of the spinal bone anatomy is required for the procedure to succeed. The current standard of care is called the 'blind approach' (i.e. without medical imaging) and involves a physician manually palpating a patient's back to locate spinal bone landmarks. The needle is then inserted with respect to the location of the landmarks and inserted until a loss-of-resistance is manually detected. This approach, while most common, has been associated with success rates as low as 68% in obese patients (2).

Alternative methods have been investigated for this problem, including ultrasound (US) guidance, which offers real-time imaging. Several studies have demonstrated ultrasound's efficacy for spinal anesthesia (1-6). However, standard US systems are engineered to image soft tissue rather than bone structures, with the consequence that bone is imaged poorly. US images are often degraded by a number of noise sources including speckle noise, reverberations and off-axis scattering, particularly when bone is present, making visualization of bone anatomy features difficult. Moreover, arranging access to ultrasound for the purpose of spinal anesthesia alone is cumbersome. Thus, the efficacy of guided spinal anesthesia and diagnostic procedures using standard ultrasound systems is limited and the benefits that it offers are heavily dependent on the user's familiarity and skill with ultrasonography (4).

Recently, new medical imaging technologies have been developed at Rivanna Medical, LLC to address the significant clinical need for technological advances that improve the placement of spinal anesthesia, epidural analgesia and other diagnostic procedures. The Accuro is a pocket-sized and battery operated ultrasound instrument that incorporates new signal processing-based technologies for enhanced bone imaging including 3D navigation of the lumbar spine. The device is a single self-contained unit consisting of an ultrasound system, ultrasound probe, and rotatable touchscreen display. The instrument enables a SpineView3D™ technology to facilitate spinal anesthesia guidance with real-time 3D navigation of the lumbar spine anatomy.

SpineView3D™ technology facilitates image interpretation of individual 2D lumbar spine scans by automating spinal bone landmark detection and depth measurements and providing a real-time assessment of scan plane orientation in 3D. SpineView3D™ makes image interpretation and measurements of the lumbar spine anatomy simple, quick, and easy. Real-time 2D scans from either SpineView3D™ or general-purpose bone presets are formed using patent-pending BoneEnhance+™ technology. The BoneEnhance+™ technology provides images of bone anatomy at greater bone-to-tissue contrast compared with conventional ultrasound image reconstructions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

130

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

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Health System

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 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients between the ages of 18 and 40 presenting for delivery and planning epidural anesthesia.

Description

Inclusion Criteria:

Patients between the ages of 18 and 40 presenting for delivery and planning epidural anesthesia

  • ASA-1 and ASA-2
  • BMI > 30

Exclusion Criteria:

Patients with known spinal deformities allergies to ultrasound gel

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control group (CG):
Standard practice group
Procedure: Control group (CG): standard practice
Standard practice group
Other Names:
  • CG
Ultrasound group (UG):
SpineView3D™ anatomical "scouting" approach
Procedure: Ultrasound group (UG):
SpineView3D™ anatomical "scouting" approach
Other Names:
  • UG
Device: Accuro SpineView3D™
subject will be scanned with 'Accuro SpineView3D
Other Names:
  • scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rates:
Time Frame: 1 day
defined as successful epidural administration on the first needle insertion attempt.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Collaborators

Rivanna Medical, LLC

Investigators

  • Principal Investigator: Mohammed Tiouririne, MD, UVA Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2016

Primary Completion (Actual)

January 12, 2018

Study Completion (Actual)

January 12, 2018

Study Registration Dates

First Submitted

May 8, 2015

First Submitted That Met QC Criteria

May 12, 2015

First Posted (Estimate)

May 13, 2015

Study Record Updates

Last Update Posted (Actual)

March 10, 2022

Last Update Submitted That Met QC Criteria

March 9, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • Rivanna Clin-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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