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Collaboration Live is a prospective, single-arm clinical study of subjects who provide written consent. Subjects are scanned using a Philips EPIQ 5 or EPIQ 7 Ultrasound System equipped with Collaboration Live software. The study investigator will evaluate performance of the Collaboration Live tool with regard to performance of conferencing, sharing and control capabilities. Adverse events will be reported and the study investigator will assess potential relationship to the study device or study procedure. Additionally, the utility of Collaboration Live in remote consult of study patients will be evaluated. No patient follow-up beyond the initial consultation will be conducted with the Collaboration Live software solution.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental - Collaboration Live software | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-diagnostic software solution | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Clinically Acceptable Performance of Remote Control Functionality | 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 | Intra-procedural (1 day) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Technical Issues | Number of subjects for which device deficiencies are reported | Intra-procedural (1 day) |
| Success Rates for Key Tasks in the Collaborative Exam | Establishing the remote connection, establishing text chat, establishing voice call, establishing webcam feed, establishing screen share, establishing remote control |
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Inclusion Criteria:
Exclusion Criteria:
Subject in indicated for a routine OB/GYN ultrasound examination at the site.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Perinatal Associates of New Mexico | Albuquerque | New Mexico | 87106 | United States | ||
| Perinatal Associates of New Mexico |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Clinically Acceptable Performance of Remote Control Functionality | 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 | Posted | Number | 95% Confidence Interval | Percentage of total exams | Intra-procedural (1 day) |
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| T.J. Battisti | Philips | (425) 205-3515 | t.j.battisti@philips.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 16, 2020 | Oct 1, 2020 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Oct 24, 2019 | Oct 1, 2020 | Prot_001.pdf |
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|
| Intra-procedural (1 day) |
| Travel Reduction Attributable to Use of Collaboration Live | Distance between the scanning facility and the investigator's location will be recorded (in miles). | Intra-procedural (1 day) |
| Ease of Use | 5-point (Likert) scale data will be reported by the investigator.( 5 = Strongly agree, 4 = Agree, 3 = Neutral, 2 = Disagree, 1 = Strongly disagree) | Intra-procedural (1 day) |
| User Feedback Regarding Streaming, Image Quality and Overall Experience | 5-point (Likert) scale data will be reported by the investigator. ( 5 = Very good, 4 = Good, 3 = Acceptable, 2 = Poor, 1 = Very Poor) | Intra-procedural (1 day) |
| Patient Feedback Regarding Remote Consultation | Tele-medicine Satisfaction Questionnaire | 1 day |
| Impact of Remote Consultation on Reimbursement | Submitted charges and reimbursement rates for remote patient consultation data will be recorded and compared to standard rates for in-person consultation | 30 days |
| Rio Rancho |
| New Mexico |
| 87124 |
| United States |
| Perinatal Associates of New Mexico | Santa Fe | New Mexico | 87505 | United States |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Gestational age | Mean | Standard Deviation | weeks |
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| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
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| Units | Counts |
|---|---|
| Participants |
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| Secondary | Number of Participants With Technical Issues | Number of subjects for which device deficiencies are reported | Posted | Count of Participants | Participants | Intra-procedural (1 day) |
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| Secondary | Success Rates for Key Tasks in the Collaborative Exam | Establishing the remote connection, establishing text chat, establishing voice call, establishing webcam feed, establishing screen share, establishing remote control | Posted | Number | percentage of participants | Intra-procedural (1 day) |
|
|
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| Secondary | Travel Reduction Attributable to Use of Collaboration Live | Distance between the scanning facility and the investigator's location will be recorded (in miles). | Posted | Mean | Standard Deviation | miles | Intra-procedural (1 day) |
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| Secondary | Ease of Use | 5-point (Likert) scale data will be reported by the investigator.( 5 = Strongly agree, 4 = Agree, 3 = Neutral, 2 = Disagree, 1 = Strongly disagree) | Posted | Count of Participants | Participants | Intra-procedural (1 day) |
|
|
|
| Secondary | User Feedback Regarding Streaming, Image Quality and Overall Experience | 5-point (Likert) scale data will be reported by the investigator. ( 5 = Very good, 4 = Good, 3 = Acceptable, 2 = Poor, 1 = Very Poor) | Posted | Count of Participants | Participants | Intra-procedural (1 day) |
|
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| Secondary | Patient Feedback Regarding Remote Consultation | Tele-medicine Satisfaction Questionnaire | Posted | Count of Participants | Participants | 1 day |
|
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| Secondary | Impact of Remote Consultation on Reimbursement | Submitted charges and reimbursement rates for remote patient consultation data will be recorded and compared to standard rates for in-person consultation | Posted | Mean | Standard Deviation | percentage of standard amount | 30 days |
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| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
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| Agree |
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| Sonorapher |
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