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

Usability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04182165
• Other study ID #: CUBX-08
• Status: Completed
• Phase: N/A
• Start date: December 10, 2019
• Est. completion date: April 1, 2020

Study information

• Verified date: January 2020
• Source: ContinUse Biometrics Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 1, 2020
• Est. primary completion date: February 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Usability

Intervention

Device:
• Gili BioSensor System/ Gili Pro X BioSensor System
Usability study

Locations

Country	Name	City	State
Israel	Tel Aviv Sourasky Medical Center (TASMC)	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
ContinUse Biometrics Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

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