Collaboration Live

Collaboration Live Clinical Study

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Related
• Intervention / Treatment: Device: Non-diagnostic software solution

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Perinatal Associates of New Mexico
    • Rio Rancho, New Mexico, United States, 87124
      • Perinatal Associates of New Mexico
    • Santa Fe, New Mexico, United States, 87505
      • Perinatal Associates of New Mexico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Experimental - Collaboration Live software

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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Philips Clinical & Medical Affairs Global

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2020
• Primary Completion (Actual): February 20, 2020
• Study Completion (Actual): February 20, 2020

Study Registration Dates

• First Submitted: January 21, 2020
• First Submitted That Met QC Criteria: January 24, 2020
• First Posted (Actual): January 28, 2020

Study Record Updates

• Last Update Posted (Actual): December 4, 2020
• Last Update Submitted That Met QC Criteria: November 10, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Ultrasound; Telemedicine; Collaboration Live
• Other Study ID Numbers: US-GIS-10649

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes