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

This study has been completed.

Sponsors and Collaborators: Hadassah Medical Organization
Walter Reed Army Medical Center
Information provided by: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00571077
  Purpose

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 Intervention
Thyroid Neoplasms
Thyroid Nodules
Device: Electrical Impedance Scanning (EIS) of the Thyroid gland

MedlinePlus related topics:   Cancer    Nuclear Scans    Thyroid Cancer   

ChemIDplus related topics:   Thyroid   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Other, Prospective
Official Title:   Electrical Impedance Scanning of Thyroid Nodules Prior to Thyroid Surgery: a Prospective Study

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Sensitivity and specificity of EIS [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • NPV and PPV of EIS of the thyroid [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

No biospecimens are retained


Estimated Enrollment:   200
Study Start Date:   January 2002
Study Completion Date:   December 2007

Groups/Cohorts Assigned Interventions
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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00571077

Locations
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
Principal Investigator:     Aviram Nissan, MD     Hadassah-Hebrew University Medical Center    
Principal Investigator:     Alexander Stojadinovic, MD     Walter Reed Army Medical Center    
  More Information


Publications indexed to this study:

Responsible Party:   Hadassah-Hebrew University Medical Center ( Aviram Nissan )
Study ID Numbers:   1-31-7-02, EIS-T-02
First Received:   December 10, 2007
Last Updated:   May 12, 2008
ClinicalTrials.gov Identifier:   NCT00571077
Health Authority:   Israel: The Israel National Institute for Health Policy Research and Health Services Research

Keywords provided by Hadassah Medical Organization:
Thyroid neoplasms  
thyroid nodules  
electrical impedance scanning  

Study placed in the following topic categories:
Thyroid Nodule
Thyroid Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases
Endocrinopathy
Thyroid Diseases
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 07, 2008




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