Prizma Device Temperature Measurement | NCT03340441

Studies
Prizma Device Temperature Measurement

NCT03340441

Sponsor

G Medical Innovations Ltd.

Status

Unknown status

Last Update Posted

Nov 13, 2017Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Temperature Change, Body

Interventions

Prizma

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 19, 2017Actual

Primary Completion Date

Dec 1, 2017Estimated

Completion Date

Dec 30, 2017Estimated

First Submitted Date

Oct 24, 2017

First Submission Date that Met QC Criteria

Nov 8, 2017

First Posted Date

Nov 13, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 8, 2017

Last Update Posted Date

Nov 13, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prizma	Device	sensor unit with mobile application installed on smartphone		Smartphone cover / Jacket

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
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

Overall Officials

Name	Affiliation	Role
Moshe Tishler, Prof.	Asaf Harofe Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asaf Harofe Medical Center	Recruiting	Rishon LeZiyyon		70300	Israel

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001832	Body Temperature Changes

Ancestor Terms

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided