Collaboration Live

Study Overview
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Brief Summary
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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.

Official Title
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Collaboration Live Clinical Study

Conditions
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Pregnancy Related

Intervention / Treatment
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* Device: Non-diagnostic software solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is at least 18 years of age Subject in indicated for a routine Obstetrics/Gynecology ultrasound examination at the site. Subject is willing and capable of providing informed consent and participating in this study Exclusion Criteria: A medical condition or co-morbidity that would be unduly affected by study participation, per investigator discretion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Experimental - Collaboration Live software<br> | Device: Non-diagnostic software solution<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Collaboration Live, Telemedicine, Ultrasound