Prizma Device Temperature Measurement

G Medical Innovations Ltd.300 enrolled

Overview

The purpose of the study is to evaluate the temperature measurements by the Prizma device.

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 Type

OBSERVATIONAL

Enrollment

300

Conditions

Temperature Change, Body

Interventions

PrizmaDEVICE

sensor unit with mobile application installed on smartphone

Eligibility

Sex: ALLMin age: 17 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Asaf Harofe Medical Center

Rishon LeZiyyon, Israel

RECRUITING

Outcomes

Primary Outcomes

Temperature measurement

Develop and evaluate a skin to body temperature conversion table.

Time frame: 3 months

Central Contacts

Moshe Tishler, Prof.

CONTACT

972-8-977-9532 alona@asaf.health.gov.il

Peter Spiegel

CONTACT

972-8-977-9532 PSpiegel@asaf.health.gov.il

Data from ClinicalTrials.gov

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