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

NCT04179279 | Completed

• 1 other identifier: CUBX-06
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Rate; Respiratory Rate

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Safety evaluation

  During the procedure

Study Arms (2)

Pilot

Device: Gili Biosensor System (Gili Pro Biosensor)

Pivotal

Device: Gili Biosensor System (Gili Pro Biosensor)

Interventions

Gili Biosensor System (Gili Pro Biosensor) DEVICE

Non-contact monitoring of heart and respiratory rates using an optical device

Pilot; Pivotal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• ContinUse Biometrics Ltd.: lead

Study Sites (1)

Tel Aviv Sourasky Medical Center (TASMC)

Tel Aviv, Israel

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2019
• First Posted: November 27, 2019
• Study Start: October 6, 2019
• Primary Completion: January 27, 2020
• Study Completion: January 27, 2020
• Last Updated: February 19, 2020

Record last verified: 2019-11

Locations

IL (1)