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Comparative Analysis of a Non-contact Respiratory and Heart Rate Monitor Vs. a Conventional Clinically Validated Reference Monitor

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ClinicalTrials.gov Identifier: NCT04179279
Recruitment Status : Completed
First Posted : November 27, 2019
Last Update Posted : February 19, 2020
Sponsor:
Information provided by (Responsible Party):
ContinUse Biometrics Ltd.

Brief 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. 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.


Condition or disease Intervention/treatment
Heart Rate Respiratory Rate Device: Gili Biosensor System (Gili Pro Biosensor)

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Study Type : Observational
Actual Enrollment : 130 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Comparative Analysis of a Non-contact Respiratory and Heart Rate Monitor Vs. a Conventional Clinically Validated Reference Monitor
Actual Study Start Date : October 6, 2019
Actual Primary Completion Date : January 27, 2020
Actual Study Completion Date : January 27, 2020

Group/Cohort Intervention/treatment
Pilot Device: Gili Biosensor System (Gili Pro Biosensor)
Non-contact monitoring of heart and respiratory rates using an optical device

Pivotal Device: Gili Biosensor System (Gili Pro Biosensor)
Non-contact monitoring of heart and respiratory rates using an optical device




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Safety evaluation [ Time Frame: During the procedure ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted/visiting the cardiology ward and/or outpatient clinics for various indications
Criteria

Inclusion Criteria:

  • Age ≥ 18, male or female
  • Hemodynamically stable as assessed by the investigator
  • Willing and able to sign informed consent

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04179279


Locations
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Israel
Tel Aviv Sourasky Medical Center (TASMC)
Tel Aviv, Israel
Sponsors and Collaborators
ContinUse Biometrics Ltd.
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Responsible Party: ContinUse Biometrics Ltd.
ClinicalTrials.gov Identifier: NCT04179279    
Other Study ID Numbers: CUBX-06
First Posted: November 27, 2019    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No