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

NCT04182165 | Completed

• 1 other identifier: CUBX-08
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Usability

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Safety assessed by AE/SAE

  During the procedure

Study Arms (2)

Subjects measured by the study staff

EXPERIMENTAL

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

EXPERIMENTAL

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

Interventions

Gili BioSensor System/ Gili Pro X BioSensor System DEVICE

Usability study

Subjects measured by the study staff; Subjects measuring themselves autonomously

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• ContinUse Biometrics Ltd.: lead

Study Sites (1)

Tel Aviv Sourasky Medical Center (TASMC)

Tel Aviv, Israel

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: December 2, 2019
• Study Start: December 10, 2019
• Primary Completion: February 10, 2020
• Study Completion: April 1, 2020
• Last Updated: July 14, 2020

Record last verified: 2020-01

Locations

IL (1)