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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date November 24, 2019
First Posted Date November 27, 2019
Last Update Posted Date February 19, 2020
Actual Study Start Date October 6, 2019
Actual Primary Completion Date January 27, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 26, 2019)
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 26, 2019)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Comparative Analysis of a Non-contact Respiratory and Heart Rate Monitor Vs. a Conventional Clinically Validated Reference Monitor
Official Title Comparative Analysis of a Non-contact Respiratory and Heart Rate Monitor Vs. a Conventional Clinically Validated Reference Monitor
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients admitted/visiting the cardiology ward and/or outpatient clinics for various indications
Condition
  • Heart Rate
  • Respiratory Rate
Intervention Device: Gili Biosensor System (Gili Pro Biosensor)
Non-contact monitoring of heart and respiratory rates using an optical device
Study Groups/Cohorts
  • Pilot
    Intervention: Device: Gili Biosensor System (Gili Pro Biosensor)
  • Pivotal
    Intervention: Device: Gili Biosensor System (Gili Pro Biosensor)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 26, 2019)
130
Original Estimated Enrollment Same as current
Actual Study Completion Date January 27, 2020
Actual Primary Completion Date January 27, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT04179279
Other Study ID Numbers CUBX-06
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party ContinUse Biometrics Ltd.
Study Sponsor ContinUse Biometrics Ltd.
Collaborators Not Provided
Investigators Not Provided
PRS Account ContinUse Biometrics Ltd.
Verification Date November 2019