Temple Touch Pro (TTP) Non-Invasive Core Temperature Monitoring as a Measure for Early Detection of Fever Related Infections, Including Sepsis. (TTP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03195439|
Recruitment Status : Unknown
Verified June 2017 by Medisim Ltd.
Recruitment status was: Not yet recruiting
First Posted : June 22, 2017
Last Update Posted : June 22, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Patients in ICU||Device: TTP||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Temple Touch Pro (TTP) Non-Invasive Core Temperature Monitoring as a Measure for Early Detection of Fever Related Infections, Including Sepsis.|
|Estimated Study Start Date :||October 2017|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||October 2019|
|Experimental: patients in ICU||
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.
- Continuously measure body temperature using TTP [ Time Frame: Estimated time frame of the trial is 18 months. ]During the trial, temperature measurements will be conducted using the TTP™ and currently used thermometers which are in routine use, later to be regarded as reference methods To examine the effectiveness of the TTP™ as a measure for detection of temperature changes pattern and to correlate such changes with fever related to infections such as sepsis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03195439
|Contact: Vered Nehemia, MD||02-5791921 ext firstname.lastname@example.org|
|Contact: Olga Yakov, MD||02-5791921 ext email@example.com|
|Hadassah Medical Center||Not yet recruiting|
|Jerusalem, Israel, POB 12000|
|Contact: Peter V Van Heerden, MD 02-6775976 Vernon@hadassah.org.il|
|Contact: Magde Al Barade, MD 050-8946620 Magdeaaa@hotmail.com|