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

Study Overview
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Brief Summary
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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.

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

Conditions
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Usability

Intervention / Treatment
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* Device: Gili BioSensor System/ Gili Pro X BioSensor System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects measured by the study staff<br>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<br>* Usability study<br>|
| Experimental: Subjects measuring themselves autonomously<br>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<br>* Usability study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |