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Prizma Device Temperature Measurement

Clinical Evaluation for Body Temperature Measurement Using Prizma Smart Phone Cover and Application

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03340441
Acronym
Prizma
Enrollment
300
Registered
2017-11-13
Start date
2017-04-19
Completion date
2017-12-30
Last updated
2017-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Temperature Change, Body

Brief summary

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.

Interventions

DEVICEPrizma

sensor unit with mobile application installed on smartphone

Sponsors

G Medical Innovations Ltd.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
17 Years to 70 Years

Inclusion criteria

* Signed written informed consent * Age above 18 years from both genders * ASA physical status 1-4 * Hospitalized in internal ward

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Temperature measurement3 monthsDevelop and evaluate a skin to body temperature conversion table.

Countries

Israel

Contacts

Primary ContactMoshe Tishler, Prof.
alona@asaf.health.gov.il972-8-977-9532
Backup ContactPeter Spiegel
PSpiegel@asaf.health.gov.il972-8-977-9532

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026