Usability
Conditions
Brief summary
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.
Interventions
DEVICEGili BioSensor System/ Gili Pro X BioSensor System
Usability study
Sponsors
ContinUse Biometrics Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| Safety assessed by AE/SAE | During the procedure | 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. |
Countries
Israel
Outcome results
None listed