Collaboration Live
- Conditions
- Pregnancy Related
- Interventions
- Device: Non-diagnostic software solution
- Registration Number
- NCT04243369
- Lead Sponsor
- Philips Clinical & Medical Affairs Global
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 30
- 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
- A medical condition or co-morbidity that would be unduly affected by study participation, per investigator discretion
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experimental - Collaboration Live software Non-diagnostic software solution -
- Primary Outcome Measures
Name Time Method Rate of Clinically Acceptable Performance of Remote Control Functionality 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
- Secondary Outcome Measures
Name Time Method Number of Participants With Technical Issues Intra-procedural (1 day) Number of subjects for which device deficiencies are reported
Travel Reduction Attributable to Use of Collaboration Live Intra-procedural (1 day) Distance between the scanning facility and the investigator's location will be recorded (in miles).
Ease of Use 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)
User Feedback Regarding Streaming, Image Quality and Overall Experience 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)
Patient Feedback Regarding Remote Consultation 1 day Tele-medicine Satisfaction Questionnaire
Impact of Remote Consultation on Reimbursement 30 days Submitted charges and reimbursement rates for remote patient consultation data will be recorded and compared to standard rates for in-person consultation
Success Rates for Key Tasks in the Collaborative Exam Intra-procedural (1 day) Establishing the remote connection, establishing text chat, establishing voice call, establishing webcam feed, establishing screen share, establishing remote control
Trial Locations
- Locations (1)
Perinatal Associates of New Mexico
🇺🇸Santa Fe, New Mexico, United States