- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01782183
Thermographic Characteristics of Sore Throat by Thermographic Camera (thermography)
January 26, 2016 updated by: Doron Carmi
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tel Aviv, Israel
- Primary Care Clinic of Clalit Health Services
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
1. Patients who are already treated with antibiotics
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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
|
The patient will be photographed twice by directing the camera externally to each tonsil from below the mandibular angle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
one day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation between clinical diagnosis of tonsillitis and thermal camera photo
Time Frame: one day
|
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.
|
one day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Doron Carmi, MD, Clalit health services
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2016
Primary Completion (Anticipated)
December 1, 2018
Study Completion (Anticipated)
December 1, 2018
Study Registration Dates
First Submitted
January 1, 2013
First Submitted That Met QC Criteria
January 31, 2013
First Posted (Estimate)
February 1, 2013
Study Record Updates
Last Update Posted (Estimate)
January 27, 2016
Last Update Submitted That Met QC Criteria
January 26, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- COM120017CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Fever
-
Centre Hospitalier Annecy GenevoisNot yet recruitingEmergency Call | Fever; Pediatric Fever Management; Parental AnxietyFrance
-
Karolinska InstitutetCompletedCrimean Congo Hemorrhagic FeverSweden
-
Meir Medical CenterCompleted
-
Chengdu Jinjiang Maternity and Child Health HospitalNot yet recruiting
-
Sanofi Pasteur, a Sanofi CompanyCompletedYellow Fever | Dengue | Dengue Fever | Dengue Hemorrhagic FeverUnited States
-
U.S. Army Medical Research and Development CommandBausch Health Americas, Inc.WithdrawnCrimean-Congo Hemorrhagic Fever | Lassa FeverGermany
-
Assistance Publique Hopitaux De MarseilleCompleted
-
Liverpool School of Tropical MedicineMedical Research Council; MEDEX; Mologic LtdNot yet recruitingCrimean-Congo Haemorrhagic Fever
-
Sanofi Pasteur, a Sanofi CompanyUnited States Department of DefenseCompletedDengue | Dengue Fever | Dengue Hemorrhagic FeverUnited States
-
Shaare Zedek Medical CenterCompleted
Clinical Trials on Thermal camera by Flir -HM series.
-
Ottawa Hospital Research InstituteCarleton UniversityCompleted
-
Universidad de ExtremaduraCompletedPain | Foot Diseases | MetatarsalgiaSpain