Patients in ICUTTPNCT03195439
Temple Touch Pro (TTP) Non-Invasive Core Temperature Monitoring as a Measure for Early Detection of Fever Related Infections, Including Sepsis.
A study testing TTP in people with Patients in ICU, run by Medisim Ltd at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients in ICU
- What is being tested?
- TTP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2017to Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah Medical Center
Jerusalem, POB 12000
Peter V Van Heerden, MD, 02-6775976, Vernon@hadassah.org.il
Magde Al Barade, MD, 050-8946620, Magdeaaa@hotmail.com
About this study
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.
Read the detailed description
TTP™ system, which is composed of 2 parts:
- SU - a disposable Sensor Unit patch
- MCU - e reusable Monitor Connecting Unit
The communication between the two units can be wired or wireless. The system to be used in this study is wired and the two units were connected via a Sensor Unit Cable (SCU).
The SU is attached to the temple area by a biocompatible disposable adhesive. It measures skin temperature across the temporal artery using several sensors, translates it to electrical signals and transmits those signals to the MCU. The MCU translates the electrical signals to core temperature using a special mathematical algorithm which overcomes the effect of the ambient temperature as well as the thermal properties of a specific patient. The core temperature as well as any concurrent error in the measurement process is displayed on the screen of the MCU or transmitted to the hospital VSM. The MCU has a wired connection to the hospital's VSM using Standard YSI400.
Study Objectives
The objectives of this clinical study are:
- A first objective of the clinical study is to verify the findings of a previously published study, relating to temperature pattern changes within patients who were diagnosed having sepsis , prior to its occurrence.
- A second objective is to examine the efficacy and safety of the TTP - a novel non-invasive core temperature measurement system , as a measure for continues core temperature monitoring.
- A third objective of the study, is 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.
It is estimated that the study with take 18 months to complete.
Type of Study
- A Retrospective phase.
- A prospective phase
Temperature measurements 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. The TTPTM system will be disinfected before use an alcohol-chlorhexidine solution.
- The Retrospective Phase, screening temperature data logs of patients who had sepsis or other fever related infection. Screening period shall be at least 72 hours prior to sepsis or infection detection. This part shall include 50 sepsis cases and 30 non-sepsis cases as a control.
- The Prospective Phase, measuring core temperature with the TTP and comparing it with existing technology such as rectal, esophageal or catheter or skin (by the case). The temperature data taken from each patient who will have a sepsis or other fever related infection will be analyzed to find any relation between the temperature pattern change Any medical care decision (such as microbiology cultures, additional testing, etc) will be made entirely according to existing reference standard of care. The TTP device will not influence in any way on ICU physician' decision. The TTP device purpose is only to record medical data for later evaluation and not to intertwine in medical care given to participants.
This part shall include up to 600 patients who will be monitored and analyzed during their stay in the ICU in order to get at least 30 sepsis cases.
- Conditions
- Patients in ICU
- Being tested
- TTP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TTPDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| patients in ICU | Experimental | Not described Receives: Device: TTP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Estimated time frame of the trial is 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study startOct 2017 (estimated)
- Primary completionApr 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients in ICUStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medisim Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03195439
- Sponsor's protocol ID
- 0068-17
- Acronym
- TTP
- Status last verified
- Jun 2017
- First submitted
- 12 Jun 2017
- Last updated
- 22 Jun 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temple Touch Pro (TTP) Non-Invasive Core Temperature Monitoring as a Measure for Early Detection of Fever Related Infections, Including Sepsis.
- ClinicalTrials.gov ID
- NCT03195439
- Acronym / sponsor ID
- TTP / 0068-17
- Conditions
- Patients in ICU
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Medisim LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2017 (estimated)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 22 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
TTP™ system, which is composed of 2 parts:
- SU - a disposable Sensor Unit patch
- MCU - e reusable Monitor Connecting Unit
The communication between the two units can be wired or wireless. The system to be used in this study is wired and the two units were connected via a Sensor Unit Cable (SCU).
The SU is attached to the temple area by a biocompatible disposable adhesive. It measures skin temperature across the temporal artery using several sensors, translates it to electrical signals and transmits those signals to the MCU. The MCU translates the electrical signals to core temperature using a special mathematical algorithm which overcomes the effect of the ambient temperature as well as the thermal properties of a specific patient. The core temperature as well as any concurrent error in the measurement process is displayed on the screen of the MCU or transmitted to the hospital VSM. The MCU has a wired connection to the hospital's VSM using Standard YSI400.
Study Objectives
The objectives of this clinical study are:
- A first objective of the clinical study is to verify the findings of a previously published study, relating to temperature pattern changes within patients who were diagnosed having sepsis , prior to its occurrence.
- A second objective is to examine the efficacy and safety of the TTP - a novel non-invasive core temperature measurement system , as a measure for continues core temperature monitoring.
- A third objective of the study, is 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.
It is estimated that the study with take 18 months to complete.
Type of Study
- A Retrospective phase.
- A prospective phase
Temperature measurements 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. The TTPTM system will be disinfected before use an alcohol-chlorhexidine solution.
- The Retrospective Phase, screening temperature data logs of patients who had sepsis or other fever related infection. Screening period shall be at least 72 hours prior to sepsis or infection detection. This part shall include 50 sepsis cases and 30 non-sepsis cases as a control.
- The Prospective Phase, measuring core temperature with the TTP and comparing it with existing technology such as rectal, esophageal or catheter or skin (by the case). The temperature data taken from each patient who will have a sepsis or other fever related infection will be analyzed to find any relation between the temperature pattern change Any medical care decision (such as microbiology cultures, additional testing, etc) will be made entirely according to existing reference standard of care. The TTP device will not influence in any way on ICU physician' decision. The TTP device purpose is only to record medical data for later evaluation and not to intertwine in medical care given to participants.
This part shall include up to 600 patients who will be monitored and analyzed during their stay in the ICU in order to get at least 30 sepsis cases.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients in ICU | Experimental | Device: TTP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- The Retrospective Phase
- No exclusion criteria The Prospective Phase
- Unavailable measurement site in case of head injury in the head area.
- Unavailable measurement reading during admission to ICU
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TTPTTP™ 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. | Device | patients in ICU |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TTP in people with Patients in ICU, run by Medisim Ltd at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vered Nehemia, MD (02-5791921 ext. 846, veredh@medisim.co.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuously measure body temperature using TTP (time frame: Estimated time frame of the trial is 18 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2017.