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

This study has been completed.

First Received: December 10, 2007 Last Updated: May 12, 2008 History of Changes

Sponsor:	Hadassah Medical Organization
Collaborator:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Nuclear Scans Surgery Thyroid Cancer

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

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

No publications provided by Hadassah Medical Organization

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Nissan A, Peoples GE, Abu-Wasel B, Adair CF, Prus D, Howard RS, Lenington SG, Fields SI, Freund HR, Peretz T, Burch HB, Shriver CD, Stojadinovic A. Prospective trial evaluating electrical impedance scanning of thyroid nodules before thyroidectomy: final results. Ann Surg. 2008 May;247(5):843-53.

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

Head and Neck Neoplasms
Endocrine System Diseases
Thyroid Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009