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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-10

Study Completion Date

2020-04-01

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.

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Detailed Description

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Conditions

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Usability

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Subjects measured by the study staff

Subjects measured by the study staff via the investigational device at the hospital (up to 50 subjects).

Group Type EXPERIMENTAL

Gili BioSensor System/ Gili Pro X BioSensor System

Intervention Type DEVICE

Usability study

Subjects measuring themselves autonomously

Subjects measuring themselves autonomously with the investigational device at their homes (up to 10 subjects from the first arm).

Group Type EXPERIMENTAL

Gili BioSensor System/ Gili Pro X BioSensor System

Intervention Type DEVICE

Usability study

Interventions

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Gili BioSensor System/ Gili Pro X BioSensor System

Usability study

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes