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

May 12, 2008 updated by: Hadassah Medical Organization
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jersualem, Israel, 91240
        • Hadassah-Hebrew University Medical Center
  • United States
    • District of Columbia
      • Washington DC, District of Columbia, United States
        • Walter Reed Army MEdicla Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensitivity and specificity of EIS
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
NPV and PPV of EIS of the thyroid
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Collaborators

Walter Reed Army Medical Center

Investigators

  • Principal Investigator: Alexander Stojadinovic, MD, Walter Reed Army Medical Center
  • Principal Investigator: Aviram Nissan, MD, Hadassah Medical Organization

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

December 10, 2007

First Submitted That Met QC Criteria

December 10, 2007

First Posted (Estimate)

December 11, 2007

Study Record Updates

Last Update Posted (Estimate)

May 13, 2008

Last Update Submitted That Met QC Criteria

May 12, 2008

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-31-7-02
  • EIS-T-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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