An interventional study of Gili BioSensor System/ Gili Pro X BioSensor System in Usability, sponsored by ContinUse Biometrics Ltd.. Completed at 1 site in Israel. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-14.
Sponsored by ContinUse Biometrics Ltd. · Not applicable, Interventional, and Other
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.
ContinUse Biometrics Ltd. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
Questionnaires assessed by SUS score and answered by the study staff.
Time frame: During the procedure
Questionnaires assessed by SUS score and answered by the enrolled study subjects.
Time frame: During the procedure
Measurement of vital signs (Heart rate/ Respiratory rate) acquired via the investigational device along with de-identified subject medical data.
Time frame: During the procedure
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.
Time frame: During the procedure
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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ContinUse Biometrics Ltd.