Status:
COMPLETED
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
Lead Sponsor:
IntelligentUltrasound Limited
Conditions:
Ultrasound Imaging of Anatomical Structures
Eligibility:
All Genders
18-70 years
Brief 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 ...
Detailed Description
Background: The American Society of Regional Anesthesia and Pain Medicine (ASRA) has published evidence-based assessment of ultrasound-guided regional anesthesia (Neal et al., 2010) concluding that u...
Eligibility Criteria
Inclusion
- Participant 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
- Participant exclusion criteria
- Unwilling or unable to provide informed consent.
- Involved in development of the ScanNav Anatomy PNB device.
- Trainee Inclusion criteria
- U.S. board-eligible/board-certified health practitioner who holds a qualification licensing to perform UGRA
- NOT capable or confident of independent UGRA practice
- Trainee exclusion criteria
- Unwilling or unable to provide informed consent.
- Involved in development of the ScanNav Anatomy PNB device.
- Models Inclusion Criteria
- Male or female, at least 18 years of age;
- Able to comprehend and sign the Informed Consent prior to enrolment in the study.
- To fit either BMI category: BMI \<30 OR BMI \>=30
- Model Exclusion Criteria
- Aged \<18 years of age or over 60 years or age
- Unwilling or unable to provide informed consent.
- BMI\> 39 kg/m2
- Known pathology of the area to be scanned.
Exclusion
Key Trial Info
Start Date :
May 16 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 30 2021
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04918693
Start Date
May 16 2021
End Date
November 30 2021
Last Update
April 1 2022
Active Locations (1)
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1
Oregon Health & Science University
Portland, Oregon, United States, 97239