Collaboration Live

Pregnancy Related Clinical Trial

Official title:

Collaboration Live Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04243369
• Other study ID #: US-GIS-10649
• Status: Completed
• Phase: N/A
• Start date: January 9, 2020
• Est. completion date: February 20, 2020

Study information

• Verified date: November 2020
• Source: Philips Clinical & Medical Affairs Global
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 20, 2020
• Est. primary completion date: February 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Perinatal Associates of New Mexico	Albuquerque	New Mexico
United States	Perinatal Associates of New Mexico	Rio Rancho	New Mexico
United States	Perinatal Associates of New Mexico	Santa Fe	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
Philips Clinical & Medical Affairs Global

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Intra-procedural (1 day)
Secondary	Number of Participants With Technical Issues	Number of subjects for which device deficiencies are reported	Intra-procedural (1 day)
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	Intra-procedural (1 day)
Secondary	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)
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)	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)	Intra-procedural (1 day)
Secondary	Patient Feedback Regarding Remote Consultation	Tele-medicine Satisfaction Questionnaire	1 day
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	30 days