Temple Touch Pro (TTP) Non-Invasive Core Temperature Monitoring as a Measure for Early Detection of Fever Related Infections, Including Sepsis.
TTP
1 other identifier
interventional
600
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2017
CompletedFirst Posted
Study publicly available on registry
June 22, 2017
CompletedStudy Start
First participant enrolled
October 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedJune 22, 2017
June 1, 2017
1.5 years
June 12, 2017
June 19, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Continuously measure body temperature using TTP
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.
Estimated time frame of the trial is 18 months.
Study Arms (1)
patients in ICU
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- The patients will be excluded from the trial if one of the following occurs:
- The Retrospective 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medisim Ltdlead
Study Sites (1)
Hadassah Medical Center
Jerusalem, POB 12000, Israel
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2017
First Posted
June 22, 2017
Study Start
October 1, 2017
Primary Completion
April 1, 2019
Study Completion
October 1, 2019
Last Updated
June 22, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share