Electrical Impedance Scanning of Thyroid Nodules Prior to Thyroid Surgery: a Prospective Study - Full Text View

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:

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
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

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