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Temple Touch Pro (TTP) Non-Invasive Core Temperature Monitoring as a Measure for Early Detection of Fever Related Infections, Including Sepsis.

NCT03195439 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2017-06-22

No results posted yet for this study

Summary

The study has 2 phases:

* The Retrospective Phase (50 patients were diagnosed to have sepsis according to our definition and criteria and 30 patients as a controlled cases )
* The Prospective Phase (600 patients who will be admitted and monitored in ICU in order to get at least 30 sepsis cases, according to our definition and criteria).

Measurements will be made from the forehead using the TTP's biocompatible sensor Unit that will be attached to the skin. The SU will transfer data to the MCU.

Conditions

  • Patients in ICU

Interventions

DEVICE

TTP

TTP™ allows to continuously measure body temperature using a new non-invasive method, and was cleared for marketing by US FDA (K150160) for as a temperature monitoring system intended to measure and monitor core body temperature of patients of all ages, by applying a sensor unit on the forehead.

Sponsors & Collaborators

  • Medisim Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-31
Primary Completion
2019-04-30
Completion
2019-10-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03195439 on ClinicalTrials.gov