UsabilityNCT04182165
Non-Contact Monitoring of Subjects With an Optical Device: A Pilot Usability Study
A study testing Gili BioSensor System/ Gili Pro X BioSensor System in people with Usability, run by ContinUse Biometrics Ltd. at 1 site in Israel.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Usability
- What is being tested?
- Gili BioSensor System/ Gili Pro X BioSensor System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteIsrael
- Study dates
- 10 Dec 2019to 1 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years of age, male or female
- Hemodynamically stable as assessed by the investigator
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
This is a single-center, prospective study in subjects visiting TASMC for various indications.
This study will be divided into two arms:
Read more
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
- Being tested
- Gili BioSensor System/ Gili Pro X BioSensor System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gili BioSensor System/ Gili Pro X BioSensor SystemDevice
Usability study
| Study group | Role | What they receive |
|---|---|---|
| Subjects measured by the study staff | Experimental | Subjects measured by the study staff via the investigational device at the hospital (up to 50 subjects). Receives: 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). Receives: Device: Gili BioSensor System/ Gili Pro X BioSensor System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaires assessed by SUS score and answered by the study staff.
Measured: During the procedure
Questionnaires assessed by SUS score and answered by the enrolled study subjects.
Measured: During the procedure
Measurement of vital signs (Heart rate/ Respiratory rate) acquired via the investigational device along with de-identified subject medical data.
Measured: During the procedure
Secondary outcomes (1)
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.
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start10 Dec 2019
- Primary completion10 Feb 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UsabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- ContinUse Biometrics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04182165
- Sponsor's protocol ID
- CUBX-08
- Status last verified
- Jan 2020
- First submitted
- 26 Nov 2019
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Contact Monitoring of Subjects With an Optical Device: A Pilot Usability Study
- ClinicalTrials.gov ID
- NCT04182165
- Acronym / sponsor ID
- CUBX-08
- Conditions
- Usability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- ContinUse Biometrics Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 2 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects measured by the study staff | Experimental | Device: Gili BioSensor System/ Gili Pro X BioSensor SystemSubjects measured by the study staff via the investigational device at the hospital (up to 50 subjects). |
| Subjects measuring themselves autonomously | Experimental | Device: Gili BioSensor System/ Gili Pro X BioSensor SystemSubjects measuring themselves autonomously with the investigational device at their homes (up to 10 subjects from the first arm). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years of age, male or female
- Hemodynamically stable as assessed by the investigator
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gili BioSensor System/ Gili Pro X BioSensor SystemUsability study | Device | Subjects measured by the study staff, Subjects measuring themselves autonomously |
Primary outcome
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
1 secondary outcome
Safety assessed by AE/SAE
Time frame: During the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
Related trials for Usability
Recruiting
Telerehabilitation Compared With Clinic-Based Physiotherapy in Children With Spastic Cerebral Palsy
Spastic Cerebral Palsy
Not yet recruiting
Usability of the FTEXES Wearable Textile Platform for Functional Electrical Stimulation and EMG
Motor Disorders, Neuromuscular Diseases
Recruiting
Technology-Based Intervention Pilot Testing
Dementia, Elder Abuse
Not yet recruiting
Hangeoreum: A Self-Paced Web-Based Program for Loneliness and Connectedness Among Korean Immigrants Aged 50 and Older
Loneliness, Korean
Recruiting
Hand Prosthesis Usability and Performance
Amputation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gili BioSensor System/ Gili Pro X BioSensor System in people with Usability, run by ContinUse Biometrics Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaires assessed by SUS score and answered by the study staff. (time frame: During the procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.