Body Temperature MeasurementNCT03452020
Evaluation of the Tyto Thermometer When Used in Clinical Care Setting
A study of Body Temperature Measurement, run by Tyto Care Ltd at 1 site in Israel.
Trial summary
Patients who present to the Emergency Department will be evaluated for eligibility to the study. Those meeting all the inclusion criteria and none of the exclusion criteria will undergo an informed consent process and will sign a written consent. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Body Temperature Measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteIsrael
- Study dates
- 24 Jan 2018to 24 Jun 2018
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Male or female, of any age
- Subject or Parent/Guardian: able to communicate with study personnel;
- Subject or Parent/Guardian: able to understand the nature of the study and provide written informed consent
- Subject or Parent/Guardian willing to comply with study procedures
Who cannot join
- Cognitive impairment, history of dementia, psychiatric disorders, mental disorders or PDD.
- Subject or legal guardian unwilling to sign informed consent form
- Those with signs or recent history of inflammation or infection of the forehead or at the Reference Clinical Test site (site of temperature measurement in any one of the devices used).
- Subjects currently using cooling blankets, ice on their forehead or fans.
- Subjects receiving treatment with antipyretics, barbiturates, antipsychotics for the past 3 hours.
- Subjects receiving current systemic treatment with thyroid preparations, corticosteroids or underwent immunizations during the past 7 days.
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- Subjects with documented illicit drug use or alcoholic intoxication
- Those participating in a clinical trial of an investigational medicinal product
- Carriers of multi drug resistant bacteria
- Pregnancy
- CTAS score of 1-2
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Schneider Children's Medical Center of Israel
Petah Tikva
Assaf Sharabi, MD, 972544747245, AssafSh@clalit.org.il
About this study
Patients who present to the Emergency Department will be evaluated for eligibility to the study. Those meeting all the inclusion criteria and none of the exclusion criteria will undergo an informed consent process and will sign a written consent. Within each age group both afebrile and febrile patients will be represented.
The patients will be divided into 3 study groups by age:
Group 1: up to 1 year Group 2: 1 to 5 years Group 3: older than 5 years
The following temperature measurements will be taken:
- Three temperature measurements using the Tyto thermometer
- Temperature measurement using the standard of care
- Three temperature measurements using the predicate device
- Conditions
- Body Temperature Measurement
- Being tested
- Temperature measurementsusing the Tyto thermometer, the standard of care thermometer and the predicate thermometer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temperature measurementsusing the Tyto thermometer, the standard of care thermometer and the predicate thermometerDevice
Temperature measurements using the Tyto thermometer, the standard of care thermometer and the predicate thermometer
| Study group | Role | What they receive |
|---|---|---|
| Tyto Thermometer, SoC Thermometer, Predicate IR Th | Other | All the study participants undergo temperature measurements with:
1. Tyto Thermometer
2. Standard of Care thermometer
3. Predicate IR thermometer Receives: Device: Temperature measurementsusing the Tyto thermometer, the standard of care thermometer and the predicate thermometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body temperature measurement
Measured: a period of no more than 12 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start24 Jan 2018
- Primary completion24 Jun 2018 (estimated)
- Study completion24 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Temperature MeasurementStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tyto Care Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yehezkel Waisman, Prof., Principal investigator, Director, Department of Emergency Medicine, Schneider Children's Medical Center of Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03452020
- Sponsor's protocol ID
- 790-00038
- Status last verified
- Feb 2018
- First submitted
- 14 Feb 2018
- Last updated
- 2 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Tyto Thermometer When Used in Clinical Care Setting
- ClinicalTrials.gov ID
- NCT03452020
- Acronym / sponsor ID
- 790-00038
- Conditions
- Body Temperature Measurement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Tyto Care LtdIndustry (pharma, biotech, devices)
- Study start
- 24 Jan 2018 (actual)
- Primary completion
- 24 Jun 2018 (estimated)
- Study completion
- 24 Jun 2018 (estimated)
- First posted
- 2 Mar 2018 (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.
Patients who present to the Emergency Department will be evaluated for eligibility to the study. Those meeting all the inclusion criteria and none of the exclusion criteria will undergo an informed consent process and will sign a written consent. Within each age group both afebrile and febrile patients will be represented.
The patients will be divided into 3 study groups by age:
Group 1: up to 1 year Group 2: 1 to 5 years Group 3: older than 5 years
The following temperature measurements will be taken:
- Three temperature measurements using the Tyto thermometer
- Temperature measurement using the standard of care
- Three temperature measurements using the predicate device
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tyto Thermometer, SoC Thermometer, Predicate IR Th | Other | Device: Temperature measurementsusing the Tyto thermometer, the standard of care thermometer and the predicate thermometerAll the study participants undergo temperature measurements with: 1. Tyto Thermometer 2. Standard of Care thermometer 3. Predicate IR thermometer |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, of any age
- Subject or Parent/Guardian: able to communicate with study personnel;
- Subject or Parent/Guardian: able to understand the nature of the study and provide written informed consent
- Subject or Parent/Guardian willing to comply with study procedures
Key exclusion criteria (11 listed)
- Cognitive impairment, history of dementia, psychiatric disorders, mental disorders or PDD.
- Subject or legal guardian unwilling to sign informed consent form
- Those with signs or recent history of inflammation or infection of the forehead or at the Reference Clinical Test site (site of temperature measurement in any one of the devices used).
- Subjects currently using cooling blankets, ice on their forehead or fans.
- Subjects receiving treatment with antipyretics, barbiturates, antipsychotics for the past 3 hours.
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 |
|---|---|---|
| Temperature measurementsusing the Tyto thermometer, the standard of care thermometer and the predicate thermometerTemperature measurements using the Tyto thermometer, the standard of care thermometer and the predicate thermometer | Device | Tyto Thermometer, SoC Thermometer, Predicate IR Th |
Primary outcome
Body temperature measurement
Time frame: a period of no more than 12 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2018.
- Individual participant dataSharing planned: No
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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.
Yehezkel Waisman, Prof. principal investigator
Director, Department of Emergency Medicine, Schneider Children's Medical Center of Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Body Temperature Measurement, run by Tyto Care 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 4 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 2 Mar 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stella Raizelman Perry, MSc (972.72.221.0750, stellar@tytocare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body temperature measurement (time frame: a period of no more than 12 minutes). 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 2 Mar 2018.