Prizma Device Temperature Measurement

NCT ID: NCT03340441

Last Updated: 2017-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-19

Study Completion Date

2017-12-30

Brief Summary

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

Detailed Description

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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

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Temperature Change, Body

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Prizma

sensor unit with mobile application installed on smartphone

Intervention Type DEVICE

Other Intervention Names

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Smartphone cover / Jacket

Eligibility Criteria

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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
Minimum Eligible Age

17 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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G Medical Innovations Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Moshe Tishler, Prof.

Role: PRINCIPAL_INVESTIGATOR

Asaf Harofe Medical Center

Locations

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Asaf Harofe Medical Center

Rishon LeZiyyon, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Moshe Tishler, Prof.

Role: CONTACT

Phone: 972-8-977-9532

Email: [email protected]

Peter Spiegel

Role: CONTACT

Phone: 972-8-977-9532

Email: [email protected]

Facility Contacts

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Moshe Tishler, Prof.

Role: primary

Peter Spiegel

Role: backup

Other Identifiers

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CLN-7.4.7.10.10

Identifier Type: -

Identifier Source: org_study_id