Temperature Change, BodyPrizmaNCT03340441
Prizma Device Temperature Measurement
An observational study of Temperature Change, Body, run by G Medical Innovations Ltd. at 1 site in Israel.
Trial summary
The purpose of the study is to evaluate the temperature measurements by the Prizma device. Read more about this study
- Who is it for?
- Ages 17 to 70 years
- Conditions the study is for
- Temperature Change, Body
- What is being tested?
- Prizma
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- 19 Apr 2017to 30 Dec 2017
- Phase
- Observational
- 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 17 to 70 years
- All sexes
- Child, Adult, Older adult
Study population: Hospitalised adults of which the total number of febrile subjects shall not be less the 30% and not greater than 50% of all subjects.
Who may be able to join
- Signed written informed consent
- Age above 18 years from both genders
- ASA physical status 1-4
- Hospitalized in internal ward
Who cannot join
- Abuse of alcohol or illicit drugs
- History of mental retardation or any mental disease
- Skin irritation / Atopic dermatitis or any other skin condition at the area of patients palms that might affect his/her ability to hold the device appropriately
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Asaf Harofe Medical Center
Rishon LeZiyyon, 70300
Moshe Tishler, Prof., 972-8-977-9532, alona@asaf.health.gov.il
Peter Spiegel, 972-8-977-9532, PSpiegel@asaf.health.gov.il
About this study
Official title: Clinical Evaluation for Body Temperature Measurement Using Prizma Smart Phone Cover and Application
The purpose of the study is to evaluate the temperature measurements by the Prizma device.
Read the detailed description
Primary objective of this study is to compare the temperature measured by the PRIZMA to the oral and Armpit temperature measured by a gold standard device in order to develop and evaluate a skin to body temperature conversion table.
Secondary objective is to collect and compare data of ECG, Respiration and SpO2 collected from the Prizma device to the data collected from gold standard devices for reference of noise level and for future development of the PRIZMA device.
- Conditions
- Temperature Change, Body
- Being tested
- Prizma
- Medical subject headings
- Body Temperature Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrizmaDevice
Also called Smartphone cover / Jacket
sensor unit with mobile application installed on smartphone
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature measurement
Develop and evaluate a skin to body temperature conversion table.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start19 Apr 2017
- Primary completion1 Dec 2017 (estimated)
- Study completion30 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temperature Change, BodyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- G Medical Innovations Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Moshe Tishler, Prof., Principal investigator, Asaf Harofe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03340441
- Sponsor's protocol ID
- CLN-7.4.7.10.10
- Acronym
- Prizma
- Status last verified
- Nov 2017
- First submitted
- 24 Oct 2017
- Last updated
- 13 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation for Body Temperature Measurement Using Prizma Smart Phone Cover and Application
- ClinicalTrials.gov ID
- NCT03340441
- Acronym / sponsor ID
- Prizma / CLN-7.4.7.10.10
- Conditions
- Temperature Change, Body
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- G Medical Innovations Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Apr 2017 (actual)
- Primary completion
- 1 Dec 2017 (estimated)
- Study completion
- 30 Dec 2017 (estimated)
- First posted
- 13 Nov 2017 (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.
The purpose of the study is to evaluate the temperature measurements by the Prizma device.
Detailed description
Primary objective of this study is to compare the temperature measured by the PRIZMA to the oral and Armpit temperature measured by a gold standard device in order to develop and evaluate a skin to body temperature conversion table.
Secondary objective is to collect and compare data of ECG, Respiration and SpO2 collected from the Prizma device to the data collected from gold standard devices for reference of noise level and for future development of the PRIZMA device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 17 to 70 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Hospitalised adults of which the total number of febrile subjects shall not be less the 30% and not greater than 50% of all subjects.
Key inclusion criteria (4 listed)
- Signed written informed consent
- Age above 18 years from both genders
- ASA physical status 1-4
- Hospitalized in internal ward
Key exclusion criteria (3 listed)
- Abuse of alcohol or illicit drugs
- History of mental retardation or any mental disease
- Skin irritation / Atopic dermatitis or any other skin condition at the area of patients palms that might affect his/her ability to hold the device appropriately
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 |
|---|---|---|
| PrizmaAlso: Smartphone cover / Jacketsensor unit with mobile application installed on smartphone | Device | – |
Primary outcome
Temperature measurement
Time frame: 3 months
Develop and evaluate a skin to body temperature conversion table.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2017.
- 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.
Moshe Tishler, Prof. principal investigator
Asaf Harofe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Temperature Change, Body, run by G Medical Innovations 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 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: status not confirmed, as of the sponsor's last update on 13 Nov 2017. 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 Moshe Tishler, Prof. (972-8-977-9532, alona@asaf.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temperature measurement (time frame: 3 months). 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 13 Nov 2017.