ClinicalTrials.gg
Status unknownNCT03340441PrizmaUpdated Nov 13, 2017

Prizma Device Temperature Measurement

An observational study in Temperature Change, Body, sponsored by G Medical Innovations Ltd.. Status unknown at 1 site in Israel. Open to participants aged 17 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-11-13.

Sponsored by G Medical Innovations Ltd. · Observational

The sponsor has not verified this record recently (last verified Nov 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
17 Years to 70 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Temperature Change, Body
03

In context

Body Temperature Changes

97 studies on the registry are indexed under Body Temperature Changes; 20 are open to participants now.

This study's planned enrollment of 300 is above the median of 87 across 24 observational studies indexed under Body Temperature Changes.

Browse Body Temperature Changes studies →

Lead sponsor

G Medical Innovations Ltd. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
17 Years to 70 Years
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Signed written
  • Age above 18 years from both genders
  • 1-4
  • Hospitalized in internal ward

Exclusion criteria

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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Interventions

  • DevicePrizma

    sensor unit with mobile application installed on smartphone

    Also known as: Smartphone cover / Jacket

06

What researchers measure

Primary outcomes

  1. Temperature measurement

    Develop and evaluate a skin to body temperature conversion table.

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03340441
Lead sponsor
G Medical Innovations Ltd.
Responsible party
Sponsor
First posted
Nov 13, 2017
Start date
Apr 19, 2017
Primary completion
Dec 1, 2017 (estimated)
Completion
Dec 30, 2017 (estimated)
Last update
Nov 13, 2017

Study contacts

Moshe Tishler, Prof.
Contact
alona@asaf.health.gov.il
972-8-977-9532
Peter Spiegel
Contact
PSpiegel@asaf.health.gov.il
972-8-977-9532
Moshe Tishler, Prof.
principal investigator · Asaf Harofe Medical Center

Oversight

Data monitoring committee
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion