A Study to Evaluate the Performance and Potential Benefits of an Assistive Artificial Intelligenc… (NCT04918693) | Clinical Trial Compass
CompletedNot Applicable
A Study to Evaluate the Performance and Potential Benefits of an Assistive Artificial Intelligence Device ScanNav Anatomy Peripheral Nerve Block - US V1.0 for Ultrasound-guided Regional Anesthesia
United States34 participantsStarted 2021-05-16
Plain-language summary
This is a single-center, prospective study to be undertaken at University of Oregon, Portland, USA. The aim is to provide data on the clinical performance of ScanNav Anatomy PNB for identification of anatomical structures during UGRA scanning, in particular:
1. Assess the benefits of the device to intended users when supervising a trainee who is performing UGRA scanning.
2. Assess the benefits of the device when intended users perform UGRA scanning.
3. Assess risk mitigation by the intended users when performing UGRA scanning.
Who can participate
Age range18 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Completed advanced training (e.g., fellowship) in or hold a qualification related to UGRA
✓. Regularly delivers direct clinical care using UGRA, including for 'awake' surgery where indicated
✓. Member of a relevant professional society (e.g., ASA, ASRA, ESRA, RA-UK)
✓. Regularly teach UGRA in the course of their clinical work, including advanced techniques where indicated
Exclusion criteria
✕. Unwilling or unable to provide informed consent.
✕. Involved in development of the ScanNav Anatomy PNB device.
✕. U.S. board-eligible/board-certified health practitioner who holds a qualification licensing to perform UGRA
✕. NOT capable or confident of independent UGRA practice
✕. Unwilling or unable to provide informed consent.