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

Thyroid Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00571077
• Other study ID #: 1-31-7-02
• Secondary ID: EIS-T-02
• Status: Completed
• Phase: N/A
• First received: December 10, 2007
• Last updated: May 12, 2008
• Start date: January 2002
• Est. completion date: December 2007

Study information

• Verified date: December 2007
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Neoplasms
• Thyroid Nodule
• Thyroid Nodules

Intervention

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.

Locations

Country	Name	City	State
Israel	Hadassah-Hebrew University Medical Center	Jersualem
United States	Walter Reed Army MEdicla Center	Washington DC	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Hadassah Medical Organization	Walter Reed Army Medical Center

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of EIS		5 years	No
Secondary	NPV and PPV of EIS of the thyroid		5 years	No