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| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | December 10, 2007 | ||||||||
| Last Updated Date | May 12, 2008 | ||||||||
| Start Date ICMJE | January 2002 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
Sensitivity and specificity of EIS [ Time Frame: 5 years ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00571077 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
NPV and PPV of EIS of the thyroid [ Time Frame: 5 years ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Electrical Impedance Scanning of Thyroid Nodules Prior to Thyroid Surgery: a Prospective Study | ||||||||
| Official Title ICMJE | Electrical Impedance Scanning of Thyroid Nodules Prior to Thyroid Surgery: a Prospective Study | ||||||||
| Brief 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. |
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| Detailed Description | |||||||||
| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Other, Prospective | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | Device: Electrical Impedance Scanning (EIS) of the Thyroid gland | ||||||||
| Study Arms / Comparison Groups | 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. |
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| Publications * | 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. | ||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Estimated Enrollment ICMJE | 200 | ||||||||
| Completion Date | December 2007 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States, Israel | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00571077 | ||||||||
| Responsible Party | Aviram Nissan, Hadassah-Hebrew University Medical Center | ||||||||
| Study ID Numbers ICMJE | 1-31-7-02, EIS-T-02 | ||||||||
| Study Sponsor ICMJE | Hadassah Medical Organization | ||||||||
| Collaborators ICMJE | Walter Reed Army Medical Center | ||||||||
| Investigators ICMJE |
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| Information Provided By | Hadassah Medical Organization | ||||||||
| Verification Date | December 2007 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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