Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02442973 · ClinicalTrials.gov registry record
Handheld 3D Lumbar Spine Navigation: A Clinical Validation Study RM002
A clinical trial, sponsored by University of Virginia.
- Completed
- Registry status
- 130
- Enrollment target
NCT02442973 is a clinical trial that has completed, run by University of Virginia. The registered enrollment target is 130 participants.
The verdict
NCT02442973 has completed, sponsored by University of Virginia.
- COMPLETED
- Registry status
- 130 participants
- Enrollment target
Study 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
Interventions
- PROCEDURE Control group (CG): standard practice
- PROCEDURE Ultrasound group (UG):
- DEVICE Accuro SpineView3D™
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2016-02 |
| Est. Completion | 2018-01-12 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02442973
The ClinicalTrials.gov registry entry for NCT02442973 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Control group (CG): standard practice is the first listed.
NCT02442973 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02442973 about?
NCT02442973 is a clinical study titled "Handheld 3D Lumbar Spine Navigation: A Clinical Validation Study RM002". 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 s...
What is the current status of trial NCT02442973?
This trial is currently completed. The enrollment target is 130 participants. The study started on 2016-02. Estimated completion is 2018-01-12.
What interventions are being tested in trial NCT02442973?
The interventions under investigation include: Control group (CG): standard practice (PROCEDURE), Ultrasound group (UG): (PROCEDURE), Accuro SpineView3D™ (DEVICE).
Who is sponsoring clinical trial NCT02442973?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.