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Electrical Impedance Scanning of Thyroid Nodules Prior to Thyroid Surgery: a Prospective Study

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00571077
Recruitment Status : Completed
First Posted : December 11, 2007
Last Update Posted : May 13, 2008
Sponsor:
Collaborator:
Walter Reed Army Medical Center
Information provided by:
Hadassah Medical Organization

Brief Summary:
Patients over the age of 18 with thyroid nodules scheduled for surgery will undergo EIS scan. Each node will be scanned and graded form 1-5 (1=benign, 5=malignant). Results will be compared with final histopathology.

Condition or disease Intervention/treatment
Thyroid Neoplasms Thyroid Nodules Device: Electrical Impedance Scanning (EIS) of the Thyroid gland

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Study Type : Observational
Estimated Enrollment : 200 participants
Time Perspective: Prospective
Official Title: Electrical Impedance Scanning of Thyroid Nodules Prior to Thyroid Surgery: a Prospective Study
Study Start Date : January 2002
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid

Group/Cohort Intervention/treatment
A

This is a a single arm study evaluating the efficacy and accuracy of EIS in detecting malignant thyroid nodules.

PAtients with thyroid nodules scheduled for surgery will undergo EIS examination.

Device: Electrical Impedance Scanning (EIS) of the Thyroid gland
Patients will be examined in the supine position. A cylinder electrode conveying 2.5V electrical current will be held by the patient. The patient will be scanned by a probe (similar to an ultrasound probe. The examination takes 5 minutes and there is no risk or discomfort.




Primary Outcome Measures :
  1. Sensitivity and specificity of EIS [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. NPV and PPV of EIS of the thyroid [ Time Frame: 5 years ]

Biospecimen Retention:   None Retained
No biospecimens are retained


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients over the age of 18 with thyroid nodules scheduled for surgery.
Criteria

Inclusion Criteria:

  • Patients over the age of 18 with thyroid nodules scheduled for surgery.

Exclusion Criteria:

  • Pregnant patients
  • PAtients with electrical powered devices (cardiac pacemakers)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00571077


Locations
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United States, District of Columbia
Walter Reed Army MEdicla Center
Washington DC, District of Columbia, United States
Israel
Hadassah-Hebrew University Medical Center
Jersualem, Israel, 91240
Sponsors and Collaborators
Hadassah Medical Organization
Walter Reed Army Medical Center
Investigators
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Principal Investigator: Aviram Nissan, MD Hadassah Medical Organization
Principal Investigator: Alexander Stojadinovic, MD Walter Reed Army Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Aviram Nissan, Hadassah-Hebrew University Medical Center
ClinicalTrials.gov Identifier: NCT00571077    
Other Study ID Numbers: 1-31-7-02
EIS-T-02
First Posted: December 11, 2007    Key Record Dates
Last Update Posted: May 13, 2008
Last Verified: December 2007
Keywords provided by Hadassah Medical Organization:
Thyroid neoplasms
thyroid nodules
electrical impedance scanning
Additional relevant MeSH terms:
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Thyroid Nodule
Thyroid Neoplasms
Thyroid Diseases
Neoplasms
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms