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Neuraxial Ultrasound Device Study
Sponsor: Stanford University
Summary
The aim of the study is to develop a device that can eliminate failed neuraxial placements in challenging patients.The study will attempt to improve safety and efficacy of neuraxial anesthesia with high precision real-time needle visualization through automated real-time needle guidance at the bedside with an experimental device (Accuro 3S). Investigators will verify the clinical workflow for utilizing the Accuro 3S during epidural and spinal procedures and validation of needle visualization while using the device as well as anatomical guidance provided by the device during spinal imaging.The underlying bone imaging enhancement algorithms were introduced in the commercially available FDA approved Accuro. The Accuro 3S will be used to establish needle insertion point and trajectory, after which the clinician will use standard of care methods to advance the needle such as the loss of resistance method.
Official title: Real-time Spine Ultrasound Imaging System: Data Collection Study
Key Details
Gender
FEMALE
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-12-15
Completion Date
2027-12
Last Updated
2026-04-24
Healthy Volunteers
No
Interventions
Ultrasound placement device
Device to assist in placement of epidural procedure
Locations (1)
Stanford University
Stanford, California, United States