Non-Contact Monitoring of Subjects With an Optical Device: A Pilot Usability Study

This is a single-center, prospective study in subjects visiting TASMC for various indications.

This study will be divided into two arms:

First Arm - Subjects measured by the study staff via the investigational device at the hospital (up to 50 subjects).

Second Arm - subjects measuring themselves autonomously with the investigational device at their homes (up to 10 subjects from the first arm).

Hence, total number of subjects for the study will be up to N=50. All subjects will be enrolled to the study only after signing an informed consent form.

Specifically for the second arm, subjects will undergo proper training by the sponsor's representatives prior to being discharged from the hospital. Training will focus on proper operation of the device, which is also designed for autonomous use in a simple and user-friendly manner. Subjects will be asked to monitor themselves periodically for a duration of up to a week. Ongoing support will be provided by the sponsor upon subject request, either by phone, or on-premise via a dedicated support team.

For both arms, device users (either study staff in first arm or subjects in the second arm) will be requested to answer questionnaires in order to assess usability with the investigational device. In both cases, a dedicated sponsor representative will observe the users to gather objective usability data, and aid in the questionnaire filling process.

Study Overview

• Status: Completed
• Conditions: Usability
• Intervention / Treatment: Device: Gili BioSensor System/ Gili Pro X BioSensor System

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age ≥ 18 years of age, male or female
• Hemodynamically stable as assessed by the investigator

Exclusion Criteria:

• Inability to comply with study protocol as assessed by the study staff (e.g. currently suffering from tremors, afraid of using tech-based devices etc.)
• Inability to provide informed consent
• Parallel participation in another clinical study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subjects measured by the study staff; Subjects measured by the study staff via the investigational device at the hospital (up to 50 subjects).	Device: Gili BioSensor System/ Gili Pro X BioSensor System; Usability study
Experimental: Subjects measuring themselves autonomously; Subjects measuring themselves autonomously with the investigational device at their homes (up to 10 subjects from the first arm).	Device: Gili BioSensor System/ Gili Pro X BioSensor System; Usability study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Questionnaires assessed by SUS score and answered by the study staff.	During the procedure
Questionnaires assessed by SUS score and answered by the enrolled study subjects.	During the procedure
Measurement of vital signs (Heart rate/ Respiratory rate) acquired via the investigational device along with de-identified subject medical data.	During the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety assessed by AE/SAE	The Gili System functions without physical contact with the inspected subject and is designed as a class 1 laser product (fully eye safe). Consequently, we do not expect any safety issues. At the same time, any AEs occurring during both trial stages 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): December 10, 2019
• Primary Completion (Actual): February 10, 2020
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: November 26, 2019
• First Submitted That Met QC Criteria: November 27, 2019
• First Posted (Actual): December 2, 2019

Study Record Updates

• Last Update Posted (Actual): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 13, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CUBX-08

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No