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Trial Title:
Radiofrequency Ablation in Thyroid Nodules
NCT ID:
NCT01750593
Condition:
Thyroid Nodules
Conditions: Official terms:
Thyroid Nodule
Thyroid Diseases
Conditions: Keywords:
radiofrequency
thyroid
nodule
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Radiofrequency ablation of the thyroid nodule
Description:
Under USG control, the nodule will be ablated by radiofrequency with a needle that has an
active tip of 1 cm.
Arm group label:
radiofrequency ablation of thyroid nodule
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Bezmialem Vakif University medical Faculty
Address:
City:
Istanbul
Zip:
34308
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Erhan Aysan, Prof. Dr.
Email:
erhanaysan@hotmail.com
Facility:
Name:
Bezmialem Vakif University
Address:
City:
Istanbul
Zip:
34308
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Erhan Aysan, Prof
Phone:
902124531700
Phone ext:
4116
Email:
erhanaysan@hotmail.com
Contact backup:
Last name:
Yeliz Ersoy, Assoc. Prof
Phone:
902124531700
Phone ext:
4506
Email:
yelizemineersoy@yahoo.com
Facility:
Name:
Bezmialem Vakif University
Address:
City:
Istanbul
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
ERHAN AYSAN, PROF.
Phone:
902124531700
Email:
yelizemineersoy@yahoo.com
Start date:
April 2013
Completion date:
June 2014
Lead sponsor:
Agency:
Bezmialem Vakif University
Agency class:
Other
Source:
Bezmialem Vakif University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01750593
