FeverthermographyNCT01782183
Thermographic Characteristics of Sore Throat by Thermographic Camera
A study testing Thermal camera by Flir -HM series. in people with Fever and Sore Throat, run by Doron Carmi at 1 site in Israel.
Trial summary
Thermographic cameras are used to determine temperature and temperature differences. Attempts have been made to use the thermographic camera as a diagnostic tool in clinical practice. Thermographic cameras have been approved by the FDA in the diagnosis of breast cancer. Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Fever, Sore Throat
- What is being tested?
- Thermal camera by Flir -HM series.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2016to Dec 2018
- 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 5 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients aged between 5 years and 18 years who attend the primary health clinic for medical treatment with a complaint of sore throat and fever
- The control group will consist of patients with fever aged between 5 years and 18 years who attend the primary health clinic for medical treatment complaint other than sore throat
Who cannot join
- 1. Patients who are already treated with antibiotics
Trial locations and contacts
1 site in 1 country.
Israel1 site
Primary Care Clinic of Clalit Health Services
Tel Aviv
Doron Carmi, MD, 972-52-5673018, doroncr@clalit.org.il
Uri Gabbay, MD, 972-50-3433100, urigab@clalit.org.il
About this study
Thermographic cameras are used to determine temperature and temperature differences. Attempts have been made to use the thermographic camera as a diagnostic tool in clinical practice. Thermographic cameras have been approved by the FDA in the diagnosis of breast cancer. The camera absorbs infrared radiation which is discharged from the tissue and than translates it to a digital data or a photograph. The camera does not radiate and direct contact with the patient is not needed. The safety is similar to a regular optic camera. No study on thermographic characteristics of inflammation of organs has been published. The purpose of this study is to demonstrate and document these characteristics of inflammation. The correlation between the thermographic imaging and the clinical diagnosis, using routine methods, will be analyzed. The differences of thermographic imaging between an inflamed organ of a subject to a non inflamed same organ of a normal control will also be analyzed. The management of the patient will be by standard practice and will not be influenced by the thermographic camera image and the study outcome.
Read the detailed description
Patients aged between 5 years and 18 years, who attend the primary health clinic for medical treatment with a complaint of only sore throat and fever will be offered to participate in the study and have a thermal camera photo of the tonsils. The study group will consist of 100 patients. Fifty patients will be enrolled who present with sore throat and another 50 patients will be enrolled who present to the clinic for any febrile condition other than a sore throat. A parent will sign consent after the parent and child have received an explanation about the study. The patient will be photographed twice by directing the camera externally to each tonsil from below the mandibular angle. The photograph will be saved in the camera and the investigator will not be able to see the photo. The number of the photograph will be listed with the patient name. The investigator will keep the list and only he will have access to the clinical data. Thereafter a standard clinical examination will be performed and all the patients will receive standard medical treatment irrespective of their participation in the study. The description of the tonsils and the pharynx will be recorded in the patient's electronic medical file and will consist of the following information (one or more of the following options): normal tonsils and pharynx, redness of tonsils and/or pharynx, exudates on tonsils, petechiae of the palate. Patients who will not have the full description as described above will be excluded from analysis from the study. The data will be analyzed descriptively for a correlation between the clinical findings and the thermal photograph
- Conditions
- Fever, Sore Throat
- Being tested
- Thermal camera by Flir -HM series.
- Keywords
- sore throat, thermal camera photo, normal tonsils and pharynx, redness of tonsils and/or pharynx, exudates on tonsils, petechiae of the palate
- Medical subject headings
- Fever, Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal camera by Flir -HM series.Device
The patient will be photographed twice by directing the camera externally to each tonsil from below the mandibular angle
| Study group | Role | What they receive |
|---|---|---|
| Thermal camera by Flir HM series | Experimental | all patients in both study and control groups will undergo thermal camera photo of the tonsils by Flir HM series Receives: Device: Thermal camera by Flir -HM series. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the symptoms of sore throat and fever and the temperature of the tonsils as measured by the thermal photograph.
Measured: one day
Secondary outcomes (1)
Correlation between clinical diagnosis of tonsillitis and thermal camera photo
Correlation between tonsillitis characterized by redness of tonsils and/or pharynx, exudates on tonsils, petechiae of the palate and temperature of the tonsils as measured by the thermal camera photo.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2013 (estimated)
- Study startSep 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FeverStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Doron Carmi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Doron Carmi, Clalit Health Services
- Investigators
- Doron Carmi, MD, Principal investigator, Clalit Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01782183
- Sponsor's protocol ID
- COM120017CTIL
- Acronym
- thermography
- Status last verified
- Jan 2016
- First submitted
- 1 Jan 2013
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thermographic Characteristics of Sore Throat by Thermographic Camera
- ClinicalTrials.gov ID
- NCT01782183
- Acronym / sponsor ID
- thermography / COM120017CTIL
- Conditions
- Fever, Sore Throat
- Keywords
- sore throat, thermal camera photo, normal tonsils and pharynx, redness of tonsils and/or pharynx, exudates on tonsils, petechiae of the palate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Doron CarmiUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 1 Feb 2013 (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.
Thermographic cameras are used to determine temperature and temperature differences. Attempts have been made to use the thermographic camera as a diagnostic tool in clinical practice. Thermographic cameras have been approved by the FDA in the diagnosis of breast cancer. The camera absorbs infrared radiation which is discharged from the tissue and than translates it to a digital data or a photograph. The camera does not radiate and direct contact with the patient is not needed. The safety is similar to a regular optic camera. No study on thermographic characteristics of inflammation of organs has been published. The purpose of this study is to demonstrate and document these characteristics of inflammation. The correlation between the thermographic imaging and the clinical diagnosis, using routine methods, will be analyzed. The differences of thermographic imaging between an inflamed organ of a subject to a non inflamed same organ of a normal control will also be analyzed. The management of the patient will be by standard practice and will not be influenced by the thermographic camera image and the study outcome.
Detailed description
Patients aged between 5 years and 18 years, who attend the primary health clinic for medical treatment with a complaint of only sore throat and fever will be offered to participate in the study and have a thermal camera photo of the tonsils. The study group will consist of 100 patients. Fifty patients will be enrolled who present with sore throat and another 50 patients will be enrolled who present to the clinic for any febrile condition other than a sore throat. A parent will sign consent after the parent and child have received an explanation about the study. The patient will be photographed twice by directing the camera externally to each tonsil from below the mandibular angle. The photograph will be saved in the camera and the investigator will not be able to see the photo. The number of the photograph will be listed with the patient name. The investigator will keep the list and only he will have access to the clinical data. Thereafter a standard clinical examination will be performed and all the patients will receive standard medical treatment irrespective of their participation in the study. The description of the tonsils and the pharynx will be recorded in the patient's electronic medical file and will consist of the following information (one or more of the following options): normal tonsils and pharynx, redness of tonsils and/or pharynx, exudates on tonsils, petechiae of the palate. Patients who will not have the full description as described above will be excluded from analysis from the study. The data will be analyzed descriptively for a correlation between the clinical findings and the thermal photograph
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thermal camera by Flir HM series | Experimental | Device: Thermal camera by Flir -HM series.all patients in both study and control groups will undergo thermal camera photo of the tonsils by Flir HM series |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients aged between 5 years and 18 years who attend the primary health clinic for medical treatment with a complaint of sore throat and fever
- The control group will consist of patients with fever aged between 5 years and 18 years who attend the primary health clinic for medical treatment complaint other than sore throat
Key exclusion criteria (1 listed)
- 1. Patients who are already treated with antibiotics
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 |
|---|---|---|
| Thermal camera by Flir -HM series.The patient will be photographed twice by directing the camera externally to each tonsil from below the mandibular angle | Device | Thermal camera by Flir HM series |
Primary outcome
Correlation between the symptoms of sore throat and fever and the temperature of the tonsils as measured by the thermal photograph.
Time frame: one day
1 secondary outcome
Correlation between clinical diagnosis of tonsillitis and thermal camera photo
Time frame: one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2016.
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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.
Doron Carmi, MD principal investigator
Clalit Health Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermal camera by Flir -HM series. in people with Fever and Sore Throat, run by Doron Carmi 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 27 Jan 2016. 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 Doron Carmi, MD (972-52-5673018, doroncr@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between the symptoms of sore throat and fever and the temperature of the tonsils as measured by the thermal photograph. (time frame: one day). 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 27 Jan 2016; AzTrials last refreshed its copy on 8 Nov 2026.