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Completed

NCT Number: NCT04243369

Collaboration Live

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.

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Key information

Conditions

Pregnancy Related

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Perinatal Associates of New Mexico, Albuquerque, New Mexico, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-diagnostic software solution

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.

Primary outcomes

  1. Rate of Clinically Acceptable Performance of Remote Control Functionality

    Time frame: 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 outcomes

  1. Number of Participants With Technical Issues

    Time frame: Intra-procedural (1 day)

    Number of subjects for which device deficiencies are reported

  2. Success Rates for Key Tasks in the Collaborative Exam

    Time frame: Intra-procedural (1 day)

    Establishing the remote connection, establishing text chat, establishing voice call, establishing webcam feed, establishing screen share, establishing remote control

  3. Travel Reduction Attributable to Use of Collaboration Live

    Time frame: Intra-procedural (1 day)

    Distance between the scanning facility and the investigator's location will be recorded (in miles).

  4. Ease of Use

    Time frame: 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)

  5. User Feedback Regarding Streaming, Image Quality and Overall Experience

    Time frame: 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)

  6. Patient Feedback Regarding Remote Consultation

    Time frame: 1 day

    Tele-medicine Satisfaction Questionnaire

  7. Impact of Remote Consultation on Reimbursement

    Time frame: 30 days

    Submitted charges and reimbursement rates for remote patient consultation data will be recorded and compared to standard rates for in-person consultation

Sponsors and collaborators

Lead sponsor

Philips Clinical & Medical Affairs Global

Industry

Registry information

Official study title

Collaboration Live Clinical Study

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 28, 2020
Registry last updated
Dec 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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