Pregnancy RelatedNCT04243369
Collaboration Live
A study testing Non-diagnostic software solution in people with Pregnancy Related, run by Philips Clinical & Medical Affairs Global at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Non-diagnostic software solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 9 Jan 2020to 20 Feb 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- A medical condition or co-morbidity that would be unduly affected by study participation, per investigator discretion
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Perinatal Associates of New Mexico
Albuquerque, New Mexico, 87106
Perinatal Associates of New Mexico
Rio Rancho, New Mexico, 87124
Perinatal Associates of New Mexico
Santa Fe, New Mexico, 87505
About this study
Official title: 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.
- Conditions
- Pregnancy Related
- Being tested
- Non-diagnostic software solution
- Keywords
- Collaboration Live, Telemedicine, Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental - Collaboration Live software | Other | Not described Receives: Device: Non-diagnostic software solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Intra-procedural (1 day)
Secondary outcomes (7)
Number of Participants With Technical Issues
Number of subjects for which device deficiencies are reported
Measured: 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
Measured: 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).
Measured: 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)
Measured: 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)
Measured: Intra-procedural (1 day)
Patient Feedback Regarding Remote Consultation
Tele-medicine Satisfaction Questionnaire
Measured: 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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start9 Jan 2020
- Primary completion20 Feb 2020
- Study completion20 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04243369
- Sponsor's protocol ID
- US-GIS-10649
- Status last verified
- Nov 2020
- First submitted
- 21 Jan 2020
- Last updated
- 4 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaboration Live Clinical Study
- ClinicalTrials.gov ID
- NCT04243369
- Acronym / sponsor ID
- US-GIS-10649
- Conditions
- Pregnancy Related
- Keywords
- Collaboration Live, Telemedicine, Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 28 Jan 2020 (actual)
- Results
- Posted 4 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental - Collaboration Live software | Other | Device: Non-diagnostic software solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- A medical condition or co-morbidity that would be unduly affected by study participation, per investigator discretion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-diagnostic software solutionCollaboration 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. | Device | Experimental - Collaboration Live software |
Primary outcome
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
7 secondary outcomes
Number of Participants With Technical Issues
Time frame: Intra-procedural (1 day)
Success Rates for Key Tasks in the Collaborative Exam
Time frame: Intra-procedural (1 day)
Travel Reduction Attributable to Use of Collaboration Live
Time frame: Intra-procedural (1 day)
Ease of Use
Time frame: Intra-procedural (1 day)
User Feedback Regarding Streaming, Image Quality and Overall Experience
Time frame: Intra-procedural (1 day)
Patient Feedback Regarding Remote Consultation
Time frame: 1 day
Impact of Remote Consultation on Reimbursement
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-diagnostic software solution in people with Pregnancy Related, run by Philips Clinical & Medical Affairs Global at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Clinically Acceptable Performance of Remote Control Functionality (time frame: Intra-procedural (1 day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2020.