Temple Touch Pro (TTP) Non Invasive Continuous Temperature Measurement System (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. Identifier: NCT01489280
Recruitment Status : Unknown
Verified September 2012 by Medisim Ltd.
Recruitment status was:  Recruiting
First Posted : December 9, 2011
Last Update Posted : September 11, 2012
Information provided by (Responsible Party):
Medisim Ltd

Brief Summary:

In this study, the body temperatures of men and women undergoing elective surgery will be measured using the Temple Touch Pro. In the operating room, each patient's temperature will be measured with both the Temple Touch Pro and another one or two of the continuous reference methods used clinically for measuring the core temperature.

The Medisim Temple Touch Pro thermometer combines a noninvasive, biocompatible patch and a receiving unit. The former is attached to the skin, while the latter is placed near the patient or the vital signs monitor and receives data from the patch. The core temperature equivalent is displayed. The Medisim Temple Touch Pro is based on the measurements made by conductive sensors that perform skin temperature measurements and then applies a special algorithm in order to calculate the body's temperature.

Condition or disease
Body Temperature During Surgery

Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Temple Touch Pro (TTP) Non Invasive Continuous Temperature Measurement System.
Study Start Date : May 2012
Estimated Primary Completion Date : February 2014

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
ages 0 and up, patients subjected to elective surgery.

Inclusion Criteria:

The patients will be chosen for the trial if the following criteria are met:

  • Male and female patients scheduled to undergo cardiothoracic surgery and major (surgeries scheduled to last more than 90 minutes) abdominal, vascular and general surgery.
  • The surgical procedure requires temperature monitoring.
  • Informed consent signed by the patient or his legal guardian.

Exclusion Criteria:

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

  • The medical staff decides that the patient should not participate.
  • Unavailable measurement site in case of operations performed in the head area.

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 identifier (NCT number): NCT01489280

Rambam medical center Not yet recruiting
Haifa, Israel
Contact: Avraham Weissman    97248542381      
Wolfson Medical Center Recruiting
Holon, Israel
Contact: Shmuel Evron, Prof.    97235028152      
Sponsors and Collaborators
Medisim Ltd

Responsible Party: Medisim Ltd Identifier: NCT01489280     History of Changes
Other Study ID Numbers: 26-115-630
First Posted: December 9, 2011    Key Record Dates
Last Update Posted: September 11, 2012
Last Verified: September 2012

Keywords provided by Medisim Ltd:
Temple Touch Pro