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Thermographic Characteristics of Sore Throat by Thermographic Camera (thermography)

This study is currently recruiting participants.
Verified April 2013 by Clalit Health Services
Sponsor:
Information provided by (Responsible Party):
Doron Carmi, Clalit Health Services
ClinicalTrials.gov Identifier:
NCT01782183
First received: January 1, 2013
Last updated: April 21, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention
Fever
Sore Throat
 Device: Thermal camera by Flir -HM series.

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Thermographic Characteristics of Sore Throat by Thermographic Camera

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Clalit Health Services:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation between clinical diagnosis of tonsillitis and thermal camera photo [ Time Frame: one day ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 100
Study Start Date: April 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 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

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. The first patient after each patient examined for a sore throat who will not complain of a sore throat sore throat will be asked to have a thermal camera photograph and will enter the study. 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

  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01782183

Contacts
Contact: Doron Carmi, MD 972-52-5673018 doroncr@clalit.org.il
Contact: Uri Gabbay, MD 972-503433100 urigab@clalit.org.il

Locations
Israel
Primary Care Clinic of Clalit Health Services Recruiting
Tel Aviv, Israel
Contact: Doron Carmi, MD     972-52-5673018     doroncr@clalit.org.il    
Contact: Uri Gabbay, MD     972-50-3433100     urigab@clalit.org.il    
Principal Investigator: Doron Carmi, MD            
Sponsors and Collaborators
Doron Carmi
Investigators
Principal Investigator: Doron Carmi, MD Clalit Health Services
  More Information

No publications provided

Responsible Party: Doron Carmi, Medical Doctor, Clalit Health Services
ClinicalTrials.gov Identifier: NCT01782183     History of Changes
Other Study ID Numbers: COM120017CTIL
Study First Received: January 1, 2013
Last Updated: April 21, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Clalit Health Services:
sore throat
thermal camera photo
normal tonsils and pharynx
 redness of tonsils and/or pharynx
exudates on tonsils
petechiae of the palate

Additional relevant MeSH terms:
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
 Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013