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

Completed

• Conditions: Respiratory Rate; Heart Rate
• Interventions: Device: Gili Biosensor System (Gili Pro Biosensor)

• Registration Number: NCT04179279
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-06
• Status Verified: 2019-11
• Study First Submitted: 2019-11-24
• Study First Submitted QC: 2019-11-26
• Study First Posted: 2019-11-27
• Primary Completion: 2020-01-27
• Study Completion: 2020-01-27
• Last Update Submitted: 2020-02-18
• Last Update Posted: 2020-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pilot	Gili Biosensor System (Gili Pro Biosensor)	-
Pivotal	Gili Biosensor System (Gili Pro Biosensor)	-

Primary Outcome Measures

Name	Time	Method
Heart rate	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	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

Name	Time	Method
Safety evaluation	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.

Trial Locations

Locations (1)

Tel Aviv Sourasky Medical Center (TASMC); 🇮🇱 Tel Aviv, Israel