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

This study has been completed.
Sponsor:
Collaborator:
Walter Reed Army Medical Center
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00571077
First received: December 10, 2007
Last updated: May 12, 2008
Last verified: December 2007
History of Changes
  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

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

Resource links provided by NLM:

Drug Information available for: Thyroid
U.S. FDA Resources

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

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 Medical Organization
Principal Investigator: Alexander Stojadinovic, MD Walter Reed Army Medical Center
  More Information

No publications provided by Hadassah Medical Organization

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Aviram Nissan, Hadassah-Hebrew University Medical Center
ClinicalTrials.gov Identifier: NCT00571077     History of Changes
Other Study ID Numbers: 1-31-7-02, EIS-T-02
Study First Received: December 10, 2007
Last Updated: May 12, 2008
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

Additional relevant MeSH terms:
Neoplasms
Thyroid Neoplasms
Thyroid Diseases
Thyroid Nodule
 Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 18, 2013