NCT04243369

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 9, 2020

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2020

Completed
10 months until next milestone

Results Posted

Study results publicly available

December 4, 2020

Completed
Last Updated

December 4, 2020

Status Verified

November 1, 2020

Enrollment Period

1 month

First QC Date

January 21, 2020

Results QC Date

October 1, 2020

Last Update Submit

November 10, 2020

Conditions

Pregnancy Related

Keywords

Collaboration LiveTelemedicineUltrasound

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Number of Participants With Technical Issues

    Intra-procedural (1 day)

  • Success Rates for Key Tasks in the Collaborative Exam

    Intra-procedural (1 day)

  • Travel Reduction Attributable to Use of Collaboration Live

    Intra-procedural (1 day)

  • Ease of Use

    Intra-procedural (1 day)

  • User Feedback Regarding Streaming, Image Quality and Overall Experience

    Intra-procedural (1 day)

  • +2 more secondary outcomes

Study Arms (1)

Experimental - Collaboration Live software

OTHER
Device: Non-diagnostic software solution

Interventions

Non-diagnostic software solutionDEVICE

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.

Experimental - Collaboration Live software

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSubject in indicated for a routine OB/GYN ultrasound examination at the site.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • A medical condition or co-morbidity that would be unduly affected by study participation, per investigator discretion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Perinatal Associates of New Mexico

Albuquerque, New Mexico, 87106, United States

Location

Perinatal Associates of New Mexico

Rio Rancho, New Mexico, 87124, United States

Location

Perinatal Associates of New Mexico

Santa Fe, New Mexico, 87505, United States

Location

Results Point of Contact

Title
T.J. Battisti
Organization
Philips
t.j.battisti@philips.com
(425) 205-3515

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2020

First Posted

January 28, 2020

Study Start

January 9, 2020

Primary Completion

February 20, 2020

Study Completion

February 20, 2020

Last Updated

December 4, 2020

Results First Posted

December 4, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

US(3)