Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
Medisim Ltd

Brief 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.


Condition or disease Intervention/treatment Phase
Patients in ICU Device: TTP Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever Sepsis

Arm Intervention/treatment
Experimental: patients in ICU 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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Study Participants - Patients hospitalized in ICU department.

Inclusion Criteria:

The Retrospective Phase

  • Both genders (Male or Female).
  • Aged 18 years and/or above.
  • Patients were Admitted to our ICU for more than 3 days, and shall be at least 72 hours prior to sepsis or infection detection in the ICU The Prospective Phase

    • Both genders (Male or Female).
    • Aged 18 years and/or above. Patients expected to be admitted to our ICU for more than 3 days

Exclusion Criteria:

The patients will be excluded from the trial if one of the following occurs:

The Retrospective Phase

  • No exclusion criteria The Prospective Phase

    - The medical staff decides that the patien t should not participate.

  • Unavailable measurement site in case of head injury in the head area.
  • Unavailable measurement reading during admission to ICU

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Vered Nehemia, MD 02-5791921 ext 846 veredh@medisim.co.il
Contact: Olga Yakov, MD 02-5791921 ext 836 olgay@medisim.co.il

Locations
Layout table for location information
Israel
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   
Sponsors and Collaborators
Medisim Ltd

Layout table for additonal information
Responsible Party: Medisim Ltd
ClinicalTrials.gov Identifier: NCT03195439     History of Changes
Other Study ID Numbers: 0068-17
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes