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

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 Overview

• Status: Completed
• Conditions: Heart Rate; Respiratory Rate
• Intervention / Treatment: Device: Gili Biosensor System (Gili Pro Biosensor)

• Study Type: Observational
• Enrollment (Actual): 130

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel
    • Tel Aviv Sourasky Medical Center (TASMC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted/visiting the cardiology ward and/or outpatient clinics for various indications

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	During the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During the procedure

Collaborators and Investigators

• Sponsor: ContinUse Biometrics Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2019
• Primary Completion (Actual): January 27, 2020
• Study Completion (Actual): January 27, 2020

Study Registration Dates

• First Submitted: November 24, 2019
• First Submitted That Met QC Criteria: November 26, 2019
• First Posted (Actual): November 27, 2019

Study Record Updates

• Last Update Posted (Actual): February 19, 2020
• Last Update Submitted That Met QC Criteria: February 18, 2020
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: CUBX-06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No