Temple Touch Pro (TTP) Non Invasive Continuous Temperature Measurement System

NCT ID: NCT01489280

Last Updated: 2012-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Body Temperature During Surgery

Keywords

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Temple Touch Pro Medisim temperature surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medisim Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rambam medical center

Haifa, , Israel

Site Status NOT_YET_RECRUITING

Wolfson Medical Center

Holon, , Israel

Site Status RECRUITING

Countries

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Israel

Facility Contacts

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Avraham Weissman

Role: primary

Shmuel Evron, Prof.

Role: primary

Other Identifiers

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26-115-630

Identifier Type: -

Identifier Source: org_study_id