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NCT03340441 Clinical Trial

Prizma Device Temperature Measurement

Temperature Change, Body Clinical Trial

— Prizma  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03340441
Other study ID # CLN-7.4.7.10.10
Secondary ID
Status Recruiting
Phase N/A
First received October 24, 2017
Last updated November 8, 2017
Start date April 19, 2017
Est. completion date December 30, 2017

Study information
Verified date November 2017
Source G Medical Innovations Ltd.
Contact Moshe Tishler, Prof.
Phone 972-8-977-9532
Email alona@asaf.health.gov.il
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date December 30, 2017
Est. primary completion date December 1, 2017
Accepts healthy volunteers
Gender All
Age group 17 Years to 70 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Prizma
sensor unit with mobile application installed on smartphone

Locations
Country Name City State
Israel Asaf Harofe Medical Center Rishon leZion

Sponsors (1)
Lead Sponsor Collaborator
G Medical Innovations Ltd.

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Temperature measurement Develop and evaluate a skin to body temperature conversion table. 3 months
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