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Radiofrequency Ablation in Thyroid Nodules

Primary Purpose

Thyroid Nodules

Status

Unknown status

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Radiofrequency ablation of the thyroid nodule

About this trial

This is an interventional treatment trial for Thyroid Nodules focused on measuring radiofrequency, thyroid, nodule

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Bezmialem Vakif University medical FacultyRecruiting
Bezmialem Vakif UniversityRecruiting
Bezmialem Vakif UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

radiofrequency ablation of thyroid nodule

Arm Description

Under ultrasonography the thyroid nodules will be ablated by radiofrequency ablation

Outcomes

Primary Outcome Measures

Shrinkage of the thyroid nodule after radiofrequency ablation

Secondary Outcome Measures

Disappearance of the nodules in follow up

Full Information

NCT ID

NCT01750593

First Posted

October 7, 2012

Last Updated

November 27, 2013

Sponsor

Bezmialem Vakif University

1. Study Identification

Unique Protocol Identification Number

NCT01750593

Brief Title

Radiofrequency Ablation in Thyroid Nodules

Official Title

Efficacy of Radiofrequency Ablation in Thyroid Nodules

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Unknown status

Study Start Date

April 2013 (undefined)

Primary Completion Date

January 2014 (Anticipated)

Study Completion Date

June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Bezmialem Vakif University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thyroid Nodules

Keywords

radiofrequency, thyroid, nodule

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

radiofrequency ablation of thyroid nodule

Arm Type

Experimental

Arm Description

Under ultrasonography the thyroid nodules will be ablated by radiofrequency ablation

Intervention Type

Procedure

Intervention Name(s)

Radiofrequency ablation of the thyroid nodule

Intervention Description

Under USG control, the nodule will be ablated by radiofrequency with a needle that has an active tip of 1 cm.

Primary Outcome Measure Information:

Title

Shrinkage of the thyroid nodule after radiofrequency ablation

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Disappearance of the nodules in follow up

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: the presence of subjective symptoms (foreign body sensation, neck discomfort or pain, compressive symptom) or cosmetic problems; a poor surgical candidate or refusal to undergo surgery; fine-needle aspiration cytology and US findings that were compatible with a benign nodule; anxiety about a malignancy. Exclusion Criteria: a nodule less than 5 mm in size; follicular neoplasm or malignancy on fine needle aspiration cytology (FNAC); a nodule with the sonographic criteria for a malignancy (taller than wide, marked hypoechoic, microcalcifications, ill-defined margins), although FNAC was a benign result; previous radiation or operation history to the head and neck; (5) previous sclerosing therapy.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Erhan Aysan, Prof. Dr.

erhanaysan@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Yeliz Ersoy, Assoc.Prof

yelizemineersoy@yahoo.com

Facility Information:

Facility Name

Bezmialem Vakif University medical Faculty

City

Istanbul

ZIP/Postal Code

34308

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Erhan Aysan, Prof. Dr.

erhanaysan@hotmail.com

Facility Name

Bezmialem Vakif University

City

Istanbul

ZIP/Postal Code

34308

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Erhan Aysan, Prof

Phone

902124531700

Ext

4116

erhanaysan@hotmail.com

First Name & Middle Initial & Last Name & Degree

Yeliz Ersoy, Assoc. Prof

Phone

902124531700

Ext

4506

yelizemineersoy@yahoo.com

Facility Name

Bezmialem Vakif University

City

Istanbul

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

ERHAN AYSAN, PROF.

Phone

902124531700

yelizemineersoy@yahoo.com

12. IPD Sharing Statement

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Radiofrequency Ablation in Thyroid Nodules

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