Trial Outcomes & Findings for Collaboration Live (NCT NCT04243369)
NCT ID: NCT04243369
Last Updated: 2020-12-04
Results Overview
The system responds to the remote input as intended and without a delay interfering with the conduct of the exam. Additionally, a clinically acceptable exam would result in no adverse events related to the control feature
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Intra-procedural (1 day)
Results posted on
2020-12-04
Participant Flow
Participant milestones
| Measure |
Experimental - Collaboration Live Software
Non-diagnostic software solution: Collaboration Live is a non-diagnostic software solution intended for use with Philips (Philips Ultrasound, 22100 Bothell Everett Highway, Bothell, Washington 98021) EPIQ and Affiniti Series Ultrasound Systems (software version 5.0.2) that allows users to communicate (by text, voice, screen share, webcam video and remote takeover) from an ultrasound system or workstation to a remote destination.
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Overall Study
STARTED
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30
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Overall Study
COMPLETED
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30
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Collaboration Live
Baseline characteristics by cohort
| Measure |
Experimental - Collaboration Live Software
n=30 Participants
Non-diagnostic software solution: Collaboration Live is a non-diagnostic software solution intended for use with Philips (Philips Ultrasound, 22100 Bothell Everett Highway, Bothell, Washington 98021) EPIQ and Affiniti Series Ultrasound Systems (software version 5.0.2) that allows users to communicate (by text, voice, screen share, webcam video and remote takeover) from an ultrasound system or workstation to a remote destination.
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|---|---|
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Age, Continuous
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28.6 years
STANDARD_DEVIATION 7.0 • n=93 Participants
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Sex: Female, Male
Female
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30 Participants
n=93 Participants
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Sex: Female, Male
Male
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0 Participants
n=93 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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18 Participants
n=93 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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12 Participants
n=93 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=93 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=93 Participants
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Race (NIH/OMB)
White
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30 Participants
n=93 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=93 Participants
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Region of Enrollment
United States
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30 participants
n=93 Participants
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Gestational age
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27.8 weeks
STANDARD_DEVIATION 6.6 • n=93 Participants
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Body Mass Index
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34.0 kg/m^2
STANDARD_DEVIATION 7.0 • n=93 Participants
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PRIMARY outcome
Timeframe: Intra-procedural (1 day)The system responds to the remote input as intended and without a delay interfering with the conduct of the exam. Additionally, a clinically acceptable exam would result in no adverse events related to the control feature
Outcome measures
| Measure |
Experimental - Collaboration Live Software
n=30 Participants
Non-diagnostic software solution: Collaboration Live is a non-diagnostic software solution intended for use with Philips (Philips Ultrasound, 22100 Bothell Everett Highway, Bothell, Washington 98021) EPIQ and Affiniti Series Ultrasound Systems (software version 5.0.2) that allows users to communicate (by text, voice, screen share, webcam video and remote takeover) from an ultrasound system or workstation to a remote destination.
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Rate of Clinically Acceptable Performance of Remote Control Functionality
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100 Percentage of total exams
Interval 88.4 to 100.0
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SECONDARY outcome
Timeframe: Intra-procedural (1 day)Number of subjects for which device deficiencies are reported
Outcome measures
| Measure |
Experimental - Collaboration Live Software
n=30 Participants
Non-diagnostic software solution: Collaboration Live is a non-diagnostic software solution intended for use with Philips (Philips Ultrasound, 22100 Bothell Everett Highway, Bothell, Washington 98021) EPIQ and Affiniti Series Ultrasound Systems (software version 5.0.2) that allows users to communicate (by text, voice, screen share, webcam video and remote takeover) from an ultrasound system or workstation to a remote destination.
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Number of Participants With Technical Issues
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2 Participants
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SECONDARY outcome
Timeframe: Intra-procedural (1 day)Establishing the remote connection, establishing text chat, establishing voice call, establishing webcam feed, establishing screen share, establishing remote control
Outcome measures
| Measure |
Experimental - Collaboration Live Software
n=30 Participants
Non-diagnostic software solution: Collaboration Live is a non-diagnostic software solution intended for use with Philips (Philips Ultrasound, 22100 Bothell Everett Highway, Bothell, Washington 98021) EPIQ and Affiniti Series Ultrasound Systems (software version 5.0.2) that allows users to communicate (by text, voice, screen share, webcam video and remote takeover) from an ultrasound system or workstation to a remote destination.
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Success Rates for Key Tasks in the Collaborative Exam
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100 percentage of participants
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SECONDARY outcome
Timeframe: Intra-procedural (1 day)Distance between the scanning facility and the investigator's location will be recorded (in miles).
Outcome measures
| Measure |
Experimental - Collaboration Live Software
n=30 Participants
Non-diagnostic software solution: Collaboration Live is a non-diagnostic software solution intended for use with Philips (Philips Ultrasound, 22100 Bothell Everett Highway, Bothell, Washington 98021) EPIQ and Affiniti Series Ultrasound Systems (software version 5.0.2) that allows users to communicate (by text, voice, screen share, webcam video and remote takeover) from an ultrasound system or workstation to a remote destination.
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Travel Reduction Attributable to Use of Collaboration Live
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38.0 miles
Standard Deviation 18.6
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SECONDARY outcome
Timeframe: Intra-procedural (1 day)5-point (Likert) scale data will be reported by the investigator.( 5 = Strongly agree, 4 = Agree, 3 = Neutral, 2 = Disagree, 1 = Strongly disagree)
Outcome measures
| Measure |
Experimental - Collaboration Live Software
n=30 Participants
Non-diagnostic software solution: Collaboration Live is a non-diagnostic software solution intended for use with Philips (Philips Ultrasound, 22100 Bothell Everett Highway, Bothell, Washington 98021) EPIQ and Affiniti Series Ultrasound Systems (software version 5.0.2) that allows users to communicate (by text, voice, screen share, webcam video and remote takeover) from an ultrasound system or workstation to a remote destination.
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|---|---|
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Ease of Use
Physician assessment · Strongly Agree
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26 Participants
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Ease of Use
Physician assessment · Agree
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4 Participants
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Ease of Use
Sonographer Assessment · Strongly Agree
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28 Participants
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Ease of Use
Sonographer Assessment · Agree
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2 Participants
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SECONDARY outcome
Timeframe: Intra-procedural (1 day)5-point (Likert) scale data will be reported by the investigator. ( 5 = Very good, 4 = Good, 3 = Acceptable, 2 = Poor, 1 = Very Poor)
Outcome measures
| Measure |
Experimental - Collaboration Live Software
n=30 Participants
Non-diagnostic software solution: Collaboration Live is a non-diagnostic software solution intended for use with Philips (Philips Ultrasound, 22100 Bothell Everett Highway, Bothell, Washington 98021) EPIQ and Affiniti Series Ultrasound Systems (software version 5.0.2) that allows users to communicate (by text, voice, screen share, webcam video and remote takeover) from an ultrasound system or workstation to a remote destination.
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User Feedback Regarding Streaming, Image Quality and Overall Experience
Physician Assessment · Acceptable
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0 Participants
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User Feedback Regarding Streaming, Image Quality and Overall Experience
Physician Assessment · Good
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3 Participants
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User Feedback Regarding Streaming, Image Quality and Overall Experience
Physician Assessment · Very Good
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27 Participants
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User Feedback Regarding Streaming, Image Quality and Overall Experience
Sonorapher · Acceptable
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1 Participants
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User Feedback Regarding Streaming, Image Quality and Overall Experience
Sonorapher · Good
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4 Participants
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User Feedback Regarding Streaming, Image Quality and Overall Experience
Sonorapher · Very Good
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25 Participants
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SECONDARY outcome
Timeframe: 1 dayTele-medicine Satisfaction Questionnaire
Outcome measures
| Measure |
Experimental - Collaboration Live Software
n=30 Participants
Non-diagnostic software solution: Collaboration Live is a non-diagnostic software solution intended for use with Philips (Philips Ultrasound, 22100 Bothell Everett Highway, Bothell, Washington 98021) EPIQ and Affiniti Series Ultrasound Systems (software version 5.0.2) that allows users to communicate (by text, voice, screen share, webcam video and remote takeover) from an ultrasound system or workstation to a remote destination.
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Patient Feedback Regarding Remote Consultation
Good
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0 Participants
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Patient Feedback Regarding Remote Consultation
Very Good
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30 Participants
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SECONDARY outcome
Timeframe: 30 daysSubmitted charges and reimbursement rates for remote patient consultation data will be recorded and compared to standard rates for in-person consultation
Outcome measures
| Measure |
Experimental - Collaboration Live Software
n=30 Participants
Non-diagnostic software solution: Collaboration Live is a non-diagnostic software solution intended for use with Philips (Philips Ultrasound, 22100 Bothell Everett Highway, Bothell, Washington 98021) EPIQ and Affiniti Series Ultrasound Systems (software version 5.0.2) that allows users to communicate (by text, voice, screen share, webcam video and remote takeover) from an ultrasound system or workstation to a remote destination.
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Impact of Remote Consultation on Reimbursement
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96.9 percentage of standard amount
Standard Deviation 7.2
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Adverse Events
Experimental - Collaboration Live Software
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60