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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

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: NCT04918693
Recruitment Status : Completed
First Posted : June 9, 2021
Last Update Posted : April 1, 2022
Sponsor:
Information provided by (Responsible Party):
IntelligentUltrasound Limited

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 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.

Condition or disease Intervention/treatment
Ultrasound Imaging of Anatomical Structures Device: Ultrasound scanning

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Study Type : Observational
Actual Enrollment : 34 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : May 16, 2021
Actual Primary Completion Date : May 22, 2021
Actual Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anatomy

Group/Cohort Intervention/treatment
Participant
All 15 participants must be anesthesiologists who are competent to perform UGRA independently. In order to be eligible for the study, participants must be a U.S. board-eligible/board-certified and licensed Medical Doctor.
Device: Ultrasound scanning
All participants will scan with and without device and trainee on 4 models. The order of the device assistance and models will be randomized between participants, but participant will always have exposure to device first before supervising the trainee.

Trainee
All 15 trainees must be healthcare practitioners who are licensed to perform UGRA. In order to be eligible for the study, participants must be a U.S. board-eligible/board-certified health practitioner
Device: Ultrasound scanning
All participants will scan with and without device and trainee on 4 models. The order of the device assistance and models will be randomized between participants, but participant will always have exposure to device first before supervising the trainee.




Primary Outcome Measures :
  1. Obtaining the correct ultrasound view [ Time Frame: 6 months ]
    Number of participants obtaining the correct ultrasound view [majority view, at least 8/15 participants in agreement]


Secondary Outcome Measures :
  1. Identifying anatomical structures [ Time Frame: 6 months ]
    Number of participants identifying the correct anatomical structures in adult patients up to BMI 35 kg/m2 [majority view, at least 8/15 participants in agreement]

  2. Effect of supervision in anatomical structure identification [ Time Frame: 6 months ]
    Number of participants identifying the correct anatomical structures while being supervised in UGRA scanning [majority view, at least 8/15 participants in agreement]

  3. Measuring operator confidence [ Time Frame: 6 months ]
    Number of participants with improved confidence [majority view, at least 8/15 participants in agreement]

  4. Number of errors in anatomy recognition by participants [ Time Frame: 6 months ]
    Number of errors in anatomy recognition by participants [per class of safety critical structure, for all models]



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.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Participants All participants must be anesthesiologists who are competent to perform UGRA independently. In order to be eligible for the study, participants must be a U.S. board-eligible/board-certified and licensed Medical Doctor.

Trainees All trainees must be healthcare practitioners who are licensed to perform UGRA. In order to be eligible for the study, participants must be a U.S. board-eligible/board-certified health practitioner.

Models 4 models will be selected carefully based on their BMI inclusion criteria.

Criteria

Participant Inclusion criteria

  1. Completed advanced training (e.g., fellowship) in or hold a qualification related to UGRA
  2. Regularly delivers direct clinical care using UGRA, including for 'awake' surgery where indicated
  3. Member of a relevant professional society (e.g., ASA, ASRA, ESRA, RA-UK)
  4. Regularly teach UGRA in the course of their clinical work, including advanced techniques where indicated

Participant exclusion criteria

  1. Unwilling or unable to provide informed consent.
  2. Involved in development of the ScanNav Anatomy PNB device.

Trainee Inclusion criteria

  1. U.S. board-eligible/board-certified health practitioner who holds a qualification licensing to perform UGRA
  2. NOT capable or confident of independent UGRA practice

Trainee exclusion criteria

  1. Unwilling or unable to provide informed consent.
  2. Involved in development of the ScanNav Anatomy PNB device.

Models Inclusion Criteria

  1. Male or female, at least 18 years of age;
  2. Able to comprehend and sign the Informed Consent prior to enrolment in the study.
  3. To fit either BMI category: BMI <30 OR BMI >=30

Model Exclusion Criteria

  1. Aged <18 years of age or over 60 years or age
  2. Unwilling or unable to provide informed consent.
  3. BMI> 39 kg/m2
  4. Known pathology of the area to be scanned.

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): NCT04918693


Locations
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United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
IntelligentUltrasound Limited
Investigators
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Principal Investigator: Glenn Woodworth, MD Oregon Health and Science University
Principal Investigator: James Bowness, MD University of Oxford & Royal Gwent Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: IntelligentUltrasound Limited
ClinicalTrials.gov Identifier: NCT04918693    
Other Study ID Numbers: IU2021_AG_08
First Posted: June 9, 2021    Key Record Dates
Last Update Posted: April 1, 2022
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No