Heart RateNCT04179279
Comparative Analysis of a Non-contact Respiratory and Heart Rate Monitor Vs. a Conventional Clinically Validated Reference Monitor
An observational study of Heart Rate and Respiratory Rate, run by ContinUse Biometrics Ltd. at 1 site in Israel.
Trial summary
This is a prospective pivotal study in patients admitted/visiting the cardiology ward and/or outpatient clinics for various indications. The study will be conducted in two stages. The first stage will comprise a pilot study with 10 subjects, which will be completed and analyzed prior to initiation of the second stage. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Rate, Respiratory Rate
- What is being tested?
- Gili Biosensor System (Gili Pro Biosensor)
- Type of treatment
- Medical device
- How many people
- 130 participants
- Where
- 1 siteIsrael
- Study dates
- 6 Oct 2019to 27 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients admitted/visiting the cardiology ward and/or outpatient clinics for various indications
Who may be able to join
- Age ≥ 18, male or female
- Hemodynamically stable as assessed by the investigator
- Willing and able to sign informed consent
Who cannot join
- Inability to consent/comply with study protocol
- Presence of a condition that may interfere with the devices' performance (e.g. nausea, vomiting, persistent coughing, tremor, mouth breathing, etc.)
- Use of reflective garment, (e.g. sequin, silk, or similar), or highly textured garments (e.g. fur, thick lace, shaggy wool etc.).
- Parallel participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective pivotal study in patients admitted/visiting the cardiology ward and/or outpatient clinics for various indications.
The study will be conducted in two stages. The first stage will comprise a pilot study with 10 subjects, which will be completed and analyzed prior to initiation of the second stage. The two studies are independent and are included in the same protocol for logistical reasons. The second stage of the study, which will include 120 subjects, is pivotal and intended to validate the Gili BioSensor System.
Testing procedure will include seating the subject in either a steady chair in front of a table, or in bed with the bedrest raised in front of a cardiac table (or similar). The subject will be seated for 5 minutes to reach a physiological steady state. During this time, the subject will be connected to the reference device according to the manufacturer's guidelines. The investigational device will be placed on a stable surface in front of the subject (table / cardiac table or similar) and will point to the left side of the subject's chest. Both the investigational and reference devices will be temporally synchronized to maintain coordinated recording. Following the 5-minute resting period, both investigational and reference devices will be activated for a comparative recording session to acquire at least 180 seconds (3 minutes) of evaluable data. Each 60-sec interval will be used separately for comparative analyses.
- Conditions
- Heart Rate, Respiratory Rate
- Being tested
- Gili Biosensor System (Gili Pro Biosensor)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gili Biosensor System (Gili Pro Biosensor)Device
Non-contact monitoring of heart and respiratory rates using an optical device
| Study group | Role | What they receive |
|---|---|---|
| Pilot | Not described Receives: Device: Gili Biosensor System (Gili Pro Biosensor) | |
| Pivotal | Not described Receives: Device: Gili Biosensor System (Gili Pro Biosensor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
Heart rate will be compared to a reference:
- Accurate = 1 = device outcome is within ± 5 bpm or ± 10% bpm relative to reference, whichever is greater
- Inaccurate = 0 = otherwise
Measured: During the procedure
Respiratory rate
Respiratory rate will be compared to a reference:
- Accurate = 1 = device outcome is within ± 2 breaths/min relative to reference
- Inaccurate = 0 = otherwise
Measured: During the procedure
Secondary outcomes (1)
Safety evaluation
The Gili BioSensor System functions without physical contact with the inspected subject, and is compared in this study to a reference device routinely used as standard of care (SOC). Consequently, we do not expect any safety issues. At the same time, any adverse events (AE) observed during the procedure and/or during the study and/or follow-up period will be recorded in the CRF.
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start6 Oct 2019
- Primary completion27 Jan 2020
- Study completion27 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart RateStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- ContinUse Biometrics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04179279
- Sponsor's protocol ID
- CUBX-06
- Status last verified
- Nov 2019
- First submitted
- 24 Nov 2019
- Last updated
- 19 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of a Non-contact Respiratory and Heart Rate Monitor Vs. a Conventional Clinically Validated Reference Monitor
- ClinicalTrials.gov ID
- NCT04179279
- Acronym / sponsor ID
- CUBX-06
- Conditions
- Heart Rate, Respiratory Rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- ContinUse Biometrics Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Oct 2019 (actual)
- Primary completion
- 27 Jan 2020 (actual)
- Study completion
- 27 Jan 2020 (actual)
- First posted
- 27 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective pivotal study in patients admitted/visiting the cardiology ward and/or outpatient clinics for various indications.
The study will be conducted in two stages. The first stage will comprise a pilot study with 10 subjects, which will be completed and analyzed prior to initiation of the second stage. The two studies are independent and are included in the same protocol for logistical reasons. The second stage of the study, which will include 120 subjects, is pivotal and intended to validate the Gili BioSensor System.
Testing procedure will include seating the subject in either a steady chair in front of a table, or in bed with the bedrest raised in front of a cardiac table (or similar). The subject will be seated for 5 minutes to reach a physiological steady state. During this time, the subject will be connected to the reference device according to the manufacturer's guidelines. The investigational device will be placed on a stable surface in front of the subject (table / cardiac table or similar) and will point to the left side of the subject's chest. Both the investigational and reference devices will be temporally synchronized to maintain coordinated recording. Following the 5-minute resting period, both investigational and reference devices will be activated for a comparative recording session to acquire at least 180 seconds (3 minutes) of evaluable data. Each 60-sec interval will be used separately for comparative analyses.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilot | – | Device: Gili Biosensor System (Gili Pro Biosensor) |
| Pivotal | – | Device: Gili Biosensor System (Gili Pro Biosensor) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted/visiting the cardiology ward and/or outpatient clinics for various indications
Key inclusion criteria (3 listed)
- Age ≥ 18, male or female
- Hemodynamically stable as assessed by the investigator
- Willing and able to sign informed consent
Key exclusion criteria (4 listed)
- Inability to consent/comply with study protocol
- Presence of a condition that may interfere with the devices' performance (e.g. nausea, vomiting, persistent coughing, tremor, mouth breathing, etc.)
- Use of reflective garment, (e.g. sequin, silk, or similar), or highly textured garments (e.g. fur, thick lace, shaggy wool etc.).
- Parallel participation in another clinical trial
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 |
|---|---|---|
| Gili Biosensor System (Gili Pro Biosensor)Non-contact monitoring of heart and respiratory rates using an optical device | Device | Pilot, Pivotal |
Primary outcome
Heart rate
Time frame: During the procedure
Heart rate will be compared to a reference: * Accurate = 1 = device outcome is within ± 5 bpm or ± 10% bpm relative to reference, whichever is greater * Inaccurate = 0 = otherwise
Respiratory rate
Time frame: During the procedure
Respiratory rate will be compared to a reference: * Accurate = 1 = device outcome is within ± 2 breaths/min relative to reference * Inaccurate = 0 = otherwise
1 secondary outcome
Safety evaluation
Time frame: During the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Rate and Respiratory Rate, run by ContinUse Biometrics Ltd. at 1 site in Israel.
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 4 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 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Heart rate (time frame: During the procedure). The study lists 2 primary outcomes in all. 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 19 Feb 2020.