Prizma Device Temperature Measurement (Prizma)

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.

Study Overview

• Status: Unknown
• Conditions: Temperature Change, Body
• Intervention / Treatment: Device: Prizma

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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Moshe Tishler, Prof.; Phone Number: 972-8-977-9532; Email: alona@asaf.health.gov.il
• Study Contact Backup: Name: Peter Spiegel; Phone Number: 972-8-977-9532; Email: PSpiegel@asaf.health.gov.il

Study Locations

• Israel
  • Rishon leZion, Israel, 70300
    • Recruiting
    • Asaf Harofe Medical Center
    • Contact: Moshe Tishler, Prof.; Phone Number: 972-8-977-9532; Email: alona@asaf.health.gov.il
    • Contact: Peter Spiegel; Phone Number: 972-8-977-9532; Email: PSpiegel@asaf.health.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Temperature measurement	Develop and evaluate a skin to body temperature conversion table.	3 months

Collaborators and Investigators

• Sponsor: G Medical Innovations Ltd.
• Investigators: Principal Investigator: Moshe Tishler, Prof., Asaf Harofe Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2017
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 30, 2017

Study Registration Dates

• First Submitted: October 24, 2017
• First Submitted That Met QC Criteria: November 8, 2017
• First Posted (Actual): November 13, 2017

Study Record Updates

• Last Update Posted (Actual): November 13, 2017
• Last Update Submitted That Met QC Criteria: November 8, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Temperature Changes
• Other Study ID Numbers: CLN-7.4.7.10.10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No