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Radiofrequency Ablation in Thyroid Nodules

NCT ID: NCT01750593

Last Updated: 2013-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Thyroid Nodules

Keywords

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radiofrequency thyroid nodule

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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radiofrequency ablation of thyroid nodule

Under ultrasonography the thyroid nodules will be ablated by radiofrequency ablation

Group Type EXPERIMENTAL

Radiofrequency ablation of the thyroid nodule

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bezmialem Vakif University

OTHER

Sponsor Role lead

Responsible Party

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Yeliz Emine Ersoy

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bezmialem Vakif University

Istanbul, Istanbul, Turkey (Türkiye)

Site Status RECRUITING

Bezmialem Vakif University medical Faculty

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Bezmialem Vakif University

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Erhan Aysan, Prof. Dr.

Role: CONTACT

Email: [email protected]

Yeliz Ersoy, Assoc.Prof

Role: CONTACT

Email: [email protected]

Facility Contacts

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Erhan Aysan, Prof

Role: primary

Yeliz Ersoy, Assoc. Prof

Role: backup

Erhan Aysan, Prof. Dr.

Role: primary

ERHAN AYSAN, PROF.

Role: primary

Other Identifiers

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yelizeminersoy

Identifier Type: -

Identifier Source: org_study_id