Temple Touch Pro (TTP) Non Invasive Continuous Temperature Measurement System
| Tracking Information | |
|---|---|
| First Received Date ICMJE | December 7, 2011 |
| Last Updated Date | September 9, 2012 |
| Start Date ICMJE | May 2012 |
| Estimated Primary Completion Date | February 2014 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE | Not Provided |
| Original Primary Outcome Measures ICMJE | Not Provided |
| Change History | Complete list of historical versions of study NCT01489280 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Temple Touch Pro (TTP) Non Invasive Continuous Temperature Measurement System |
| Official Title ICMJE | Temple Touch Pro (TTP) Non Invasive Continuous Temperature Measurement System. |
| 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. |
| Detailed Description | Not Provided |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
| Target Follow-Up Duration | Not Provided |
| Biospecimen | Not Provided |
| Sampling Method | Non-Probability Sample |
| Study Population | ages 0 and up, patients subjected to elective surgery. |
| Condition ICMJE | Body Temperature During Surgery |
| Intervention ICMJE | Not Provided |
| Study Group/Cohort (s) | Not Provided |
| Publications * | Not Provided |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Recruiting |
| Estimated Enrollment ICMJE | 800 |
| Completion Date | Not Provided |
| Estimated Primary Completion Date | February 2014 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria: The patients will be chosen for the trial if the following criteria are met:
Exclusion Criteria: The patients will be excluded from the trial if one of the following occurs:
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| Gender | Both |
| Ages | Not Provided |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Not Provided |
| Location Countries ICMJE | Israel |
| Administrative Information | |
| NCT Number ICMJE | NCT01489280 |
| Other Study ID Numbers ICMJE | 26-115-630 |
| Has Data Monitoring Committee | No |
| Responsible Party | Medisim Ltd |
| Study Sponsor ICMJE | Medisim Ltd |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | Medisim Ltd |
| Verification Date | September 2012 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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