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Radiofrequency Ablation in Thyroid Nodules

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2013 by Yeliz Emine Ersoy, Bezmialem Vakif University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01750593
First Posted: December 17, 2012
Last Update Posted: November 28, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yeliz Emine Ersoy, Bezmialem Vakif University
  Purpose
Thyroid nodules are common problems and although > 95% are stated to be benign, they may cause some problems like hyperthyroidism, compression symptoms, and cosmesis associated with their function, size and localization. Especially for these nodules, patients undergo surgery and face up with the problems associated with surgical complications although they are not cancer. In some studies, radiofrequency ablation previously used for intrabdominal tumors like hepatic metastasis...,was stated to be efficient in the treatment of benign thyroid nodules and in some recurrent thyroid cancer cases. Therefore, the investigators decided to use this method in our patients having nodules like previously mentioned and see the efficacy and safety of the technique.

Condition Intervention
Thyroid Nodules Procedure: Radiofrequency ablation of the thyroid nodule

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Radiofrequency Ablation in Thyroid Nodules

Resource links provided by NLM:


Further study details as provided by Yeliz Emine Ersoy, Bezmialem Vakif University:

Primary Outcome Measures:
  • Shrinkage of the thyroid nodule after radiofrequency ablation [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Disappearance of the nodules in follow up [ Time Frame: 1 year ]

Estimated Enrollment: 40
Study Start Date: April 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: radiofrequency ablation of thyroid nodule
Under ultrasonography the thyroid nodules will be ablated by radiofrequency ablation
Procedure: Radiofrequency ablation of the thyroid nodule
Under USG control, the nodule will be ablated by radiofrequency with a needle that has an active tip of 1 cm.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. the presence of subjective symptoms (foreign body sensation, neck discomfort or pain, compressive symptom) or cosmetic problems;
  2. a poor surgical candidate or refusal to undergo surgery;
  3. fine-needle aspiration cytology and US findings that were compatible with a benign nodule;
  4. anxiety about a malignancy.

Exclusion Criteria:

  1. a nodule less than 5 mm in size;
  2. follicular neoplasm or malignancy on fine needle aspiration cytology (FNAC);
  3. a nodule with the sonographic criteria for a malignancy (taller than wide, marked hypoechoic, microcalcifications, ill-defined margins), although FNAC was a benign result;
  4. previous radiation or operation history to the head and neck; (5) previous sclerosing therapy.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01750593


Contacts
Contact: Erhan Aysan, Prof. Dr. erhanaysan@hotmail.com
Contact: Yeliz Ersoy, Assoc.Prof yelizemineersoy@yahoo.com

Locations
Turkey
Bezmialem Vakif University medical Faculty Recruiting
Istanbul, Turkey, 34308
Contact: Erhan Aysan, Prof. Dr.       erhanaysan@hotmail.com   
Bezmialem Vakif University Recruiting
Istanbul, Turkey, 34308
Contact: Erhan Aysan, Prof    902124531700 ext 4116    erhanaysan@hotmail.com   
Contact: Yeliz Ersoy, Assoc. Prof    902124531700 ext 4506    yelizemineersoy@yahoo.com   
Bezmialem Vakif University Recruiting
Istanbul, Turkey
Contact: ERHAN AYSAN, PROF.    902124531700    yelizemineersoy@yahoo.com   
Sponsors and Collaborators
Bezmialem Vakif University
  More Information

Responsible Party: Yeliz Emine Ersoy, M.D., Bezmialem Vakif University
ClinicalTrials.gov Identifier: NCT01750593     History of Changes
Other Study ID Numbers: yelizeminersoy
First Submitted: October 7, 2012
First Posted: December 17, 2012
Last Update Posted: November 28, 2013
Last Verified: November 2013

Keywords provided by Yeliz Emine Ersoy, Bezmialem Vakif University:
radiofrequency
thyroid
nodule

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Nodule
Endocrine System Diseases
Thyroid Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms