ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02442973
Recruitment Status : Unknown
Verified May 2016 by Mohamed Tiouririne, MD, University of Virginia.
Recruitment status was:  Recruiting
First Posted : May 13, 2015
Last Update Posted : May 4, 2016
Sponsor:
Collaborator:
Rivanna Medical, LLC
Information provided by (Responsible Party):
Mohamed Tiouririne, MD, University of Virginia

Brief Summary:

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.


Condition or disease Intervention/treatment
Pregnancy Procedure: Control group (CG): standard practice Procedure: Ultrasound group (UG): Device: Accuro SpineView3D™

Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Handheld 3D Lumbar Spine Navigation: A Clinical Validation Study RM002
Study Start Date : February 2016
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2016

Group/Cohort Intervention/treatment
Control group (CG):
Standard practice group
Procedure: Control group (CG): standard practice
Standard practice group
Other Name: CG

Ultrasound group (UG):
SpineView3D™ anatomical "scouting" approach
Procedure: Ultrasound group (UG):
SpineView3D™ anatomical "scouting" approach
Other Name: UG

Device: Accuro SpineView3D™
subject will be scanned with 'Accuro SpineView3D
Other Name: scan




Primary Outcome Measures :
  1. Success rates: [ Time Frame: 1 day ]
    defined as successful epidural administration on the first needle insertion attempt.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients between the ages of 18 and 40 presenting for delivery and planning epidural anesthesia.
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02442973


Contacts
Contact: Marcia Birk, RN 434-924-2283 meb2w@virginia.edu

Locations
United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Marcia E Birk, RN    434-924-2283    meb2w@virginia.edu   
Sponsors and Collaborators
University of Virginia
Rivanna Medical, LLC
Investigators
Principal Investigator: Mohammed Tiouririne, MD UVA Health System

Publications:
Responsible Party: Mohamed Tiouririne, MD, UVA Anesthesiology Faculty, University of Virginia
ClinicalTrials.gov Identifier: NCT02442973     History of Changes
Other Study ID Numbers: Rivanna Clin-002
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: May 4, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No