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Collaboration Live

NCT ID: NCT04243369

Last Updated: 2020-12-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-09

Study Completion Date

2020-02-20

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.

Detailed Description

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Conditions

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Pregnancy Related

Keywords

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Collaboration Live Telemedicine Ultrasound

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Experimental - Collaboration Live software

Group Type OTHER

Non-diagnostic software solution

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Philips Clinical & Medical Affairs Global

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Perinatal Associates of New Mexico

Albuquerque, New Mexico, United States

Site Status

Perinatal Associates of New Mexico

Rio Rancho, New Mexico, United States

Site Status

Perinatal Associates of New Mexico

Santa Fe, New Mexico, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

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US-GIS-10649

Identifier Type: -

Identifier Source: org_study_id