NCT03340441

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 19, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 13, 2017

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2017

Completed
Last Updated

November 13, 2017

Status Verified

November 1, 2017

Enrollment Period

8 months

First QC Date

October 24, 2017

Last Update Submit

November 8, 2017

Conditions

Temperature Change, Body

Outcome Measures

Primary Outcomes (1)

  • Temperature measurement

    Develop and evaluate a skin to body temperature conversion table.

    3 months

Interventions

PrizmaDEVICE

sensor unit with mobile application installed on smartphone

Also known as: Smartphone cover / Jacket

Eligibility Criteria

Age17 Years - 70 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Signed written informed consent
  • Age above 18 years from both genders
  • ASA physical status 1-4
  • Hospitalized in internal ward

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asaf Harofe Medical Center

Rishon LeZiyyon, 70300, Israel

RECRUITING

MeSH Terms

Conditions

Body Temperature Changes

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Moshe Tishler, Prof.

    Asaf Harofe Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Moshe Tishler, Prof.

CONTACT

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

Peter Spiegel

CONTACT

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2017

First Posted

November 13, 2017

Study Start

April 19, 2017

Primary Completion

December 1, 2017

Study Completion

December 30, 2017

Last Updated

November 13, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)