to Evaluate the Performance of the TMS Thermometer andNCT01196663
Comparison of the Performance of TMS-thermometer With Standard Esophageal or Urine Bladder Thermometer
A study testing Intraoperative temperature measurement by TMS thermometer and Esophageal or urinary bladder temperature measurement in people with to Evaluate the Performance of the TMS Thermometer and and Improve Its Algorithm, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
This Clinical study is preformed in order to estimate the performance of the TMS thermometer and to make a final tuning of the thermometer mathematical algorithm. Body temperature of men, women and children will be measured using the TMS thermometer. Read more about this study
- Who is it for?
- Ages 1 month and older
- Conditions the study is for
- to Evaluate the Performance of the TMS Thermometer and, Improve Its Algorithm
- What is being tested?
- Intraoperative temperature measurement by TMS thermometer and Esophageal or urinary bladder temperature measurement
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2008to Dec 2008
- 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 1 month and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Men, women and children that are about to have surgery which requires temperature monitoring.
- An informed consent was signed by the patient or his guardian.
Who cannot join
- The medical staff decides that the patient can't participate.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Dept of anesthesiology -Rambam health care campus
Haifa, 31096
Avi Weissman, MD, 972 4 854-2487, a_weissman@rambam.health.gov.il
Avi Weissman, MD
About this study
Official title: Clinical Evaluation of TMS (Temperature Monitoring System) Performance
This Clinical study is preformed in order to estimate the performance of the TMS thermometer and to make a final tuning of the thermometer mathematical algorithm.
Body temperature of men, women and children will be measured using the TMS thermometer.
Each Patient will be measured both with the TMS thermometer and with an esophageal or urinal thermometer as a reference.
Read the detailed description
Temperature measurement is vital during surgery. Accurate temperature reading can indicate patient's condition and alarm if something is wrong.
Nowadays, during surgeries temperature is measured mostly using an esophageal or a urinal thermometer, both of which are invasive, therefore they complicate the procedure and require time and activity of the medical stuff.
The TMS thermometer combines a noninvasive, biocompatible patch, which is attached to the body, and a receiving unit, which is placed near the body or the vital signs monitors and receives data from the patch. There is no connection between the body and the receiving unit. The measurement is based on a conductive sensor that measures the skin temperature and applies special algorithm in order to calculate the core body temperature.
The purpose of this clinical study is to evaluate the performance of the TMS thermometer and improve its algorithm by comparing its measurement to the esophageal or urinal temperature measurement
- Being tested
- Intraoperative temperature measurement by TMS thermometer, Esophageal or urinary bladder temperature measurement
- Keywords
- TMS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative temperature measurement by TMS thermometerDevice
Measurements will be taken from the patient's body using a biocompatible patch that will transfer data to the receiving unit. The patch will be sterilized before each surgery.
Esophageal or urinary bladder temperature measurementDevice
Standard temperature measurement as is being measured from patients during surgery today
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between TMS and the esophageal/urinary temperature measurements
TMS will track patient's temperature during the operation concurrently with esophageal and/or urinary temperature sensor. Correlation will be calculated between both temperature measurement methods and tracking ability of the changes in patient's temperature during the operation will be compared.
Measured: The results of this study will be presented in 6 months from today (an average)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2010 (estimated)
- Study startApr 2008
- Primary completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for to Evaluate the Performance of the TMS Thermometer andStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Investigators
- Avi Weissman, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01196663
- Sponsor's protocol ID
- TMS-thermometer-CTIL
- Status last verified
- Jul 2010
- First submitted
- 28 Jul 2010
- Last updated
- 22 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of TMS (Temperature Monitoring System) Performance
- ClinicalTrials.gov ID
- NCT01196663
- Acronym / sponsor ID
- TMS-thermometer-CTIL
- Keywords
- TMS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Dec 2008 (estimated)
- First posted
- 8 Sep 2010 (estimated)
- 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.
This Clinical study is preformed in order to estimate the performance of the TMS thermometer and to make a final tuning of the thermometer mathematical algorithm.
Body temperature of men, women and children will be measured using the TMS thermometer.
Each Patient will be measured both with the TMS thermometer and with an esophageal or urinal thermometer as a reference.
Detailed description
Temperature measurement is vital during surgery. Accurate temperature reading can indicate patient's condition and alarm if something is wrong.
Nowadays, during surgeries temperature is measured mostly using an esophageal or a urinal thermometer, both of which are invasive, therefore they complicate the procedure and require time and activity of the medical stuff.
The TMS thermometer combines a noninvasive, biocompatible patch, which is attached to the body, and a receiving unit, which is placed near the body or the vital signs monitors and receives data from the patch. There is no connection between the body and the receiving unit. The measurement is based on a conductive sensor that measures the skin temperature and applies special algorithm in order to calculate the core body temperature.
The purpose of this clinical study is to evaluate the performance of the TMS thermometer and improve its algorithm by comparing its measurement to the esophageal or urinal temperature measurement
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 1 month and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Men, women and children that are about to have surgery which requires temperature monitoring.
- An informed consent was signed by the patient or his guardian.
Key exclusion criteria (1 listed)
- The medical staff decides that the patient can't participate.
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 |
|---|---|---|
| Intraoperative temperature measurement by TMS thermometerMeasurements will be taken from the patient's body using a biocompatible patch that will transfer data to the receiving unit. The patch will be sterilized before each surgery. | Device | – |
| Esophageal or urinary bladder temperature measurementStandard temperature measurement as is being measured from patients during surgery today | Device | – |
Primary outcome
Correlation between TMS and the esophageal/urinary temperature measurements
Time frame: The results of this study will be presented in 6 months from today (an average)
TMS will track patient's temperature during the operation concurrently with esophageal and/or urinary temperature sensor. Correlation will be calculated between both temperature measurement methods and tracking ability of the changes in patient's temperature during the operation will be compared.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2010.
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.
Avi Weissman, MD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative temperature measurement by TMS thermometer and Esophageal or urinary bladder temperature measurement in people with to Evaluate the Performance of the TMS Thermometer and and Improve Its Algorithm, run by Rambam Health Care Campus 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 2 inclusion and 1 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 Sep 2010. 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 Avi Weissman, MD (972 4 854-2487, a_weissman@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between TMS and the esophageal/urinary temperature measurements (time frame: The results of this study will be presented in 6 months from today (an average)). 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 Sep 2010.