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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Diseases
Thyroid Nodule
Thyroid Neoplasms
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on September 30, 2014