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Thermographic Characteristics of Sore Throat by Thermographic Camera (thermography)

This study is not yet open for participant recruitment.
Verified January 2016 by Doron Carmi, Clalit Health Services
Sponsor:
ClinicalTrials.gov Identifier:
NCT01782183
First Posted: February 1, 2013
Last Update Posted: January 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Doron Carmi, Clalit Health Services
January 1, 2013
February 1, 2013
January 27, 2016
September 2016
December 2018   (Final data collection date for 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 ]
Same as current
Complete list of historical versions of study NCT01782183 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Thermographic Characteristics of Sore Throat by Thermographic Camera
Thermographic Characteristics of Sore Throat by Thermographic Camera
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.
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
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
  • Fever
  • Sore Throat
Device: 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
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
Intervention: Device: Thermal camera by Flir -HM series.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
December 2018
December 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 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
  2. 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

Sexes Eligible for Study: All
5 Years to 18 Years   (Child, Adult)
Yes
Contact: Doron Carmi, MD 972-52-5673018 doroncr@clalit.org.il
Contact: Uri Gabbay, MD 972-503433100 urigab@clalit.org.il
Israel
 
 
NCT01782183
COM120017CTIL
No
Not Provided
Not Provided
Doron Carmi, Clalit Health Services
Doron Carmi
Not Provided
Principal Investigator: Doron Carmi, MD Clalit Health Services
Clalit Health Services
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP