MedPath

Collaboration Live

Not Applicable
Completed
Conditions
Pregnancy Related
Interventions
Device: Non-diagnostic software solution
Registration Number
NCT04243369
Lead Sponsor
Philips Clinical & Medical Affairs Global
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
30
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 & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Experimental - Collaboration Live softwareNon-diagnostic software solution-
Primary Outcome Measures
NameTimeMethod
Rate of Clinically Acceptable Performance of Remote Control FunctionalityIntra-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 Outcome Measures
NameTimeMethod
Number of Participants With Technical IssuesIntra-procedural (1 day)

Number of subjects for which device deficiencies are reported

Travel Reduction Attributable to Use of Collaboration LiveIntra-procedural (1 day)

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

Ease of UseIntra-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)

User Feedback Regarding Streaming, Image Quality and Overall ExperienceIntra-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)

Patient Feedback Regarding Remote Consultation1 day

Tele-medicine Satisfaction Questionnaire

Impact of Remote Consultation on Reimbursement30 days

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

Success Rates for Key Tasks in the Collaborative ExamIntra-procedural (1 day)

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

Trial Locations

Locations (1)

Perinatal Associates of New Mexico

🇺🇸

Santa Fe, New Mexico, United States

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