Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-02-23 @ 6:24 AM
Study NCT ID:
NCT01750593
Status:
UNKNOWN
Last Update Posted:
2013-11-28
First Post:
2012-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiofrequency Ablation in Thyroid Nodules
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016606', 'term': 'Thyroid Nodule'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}], 'ancestors': [{'id': 'D013964', 'term': 'Thyroid Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-11-27', 'studyFirstSubmitDate': '2012-10-07', 'studyFirstSubmitQcDate': '2012-12-13', 'lastUpdatePostDateStruct': {'date': '2013-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Shrinkage of the thyroid nodule after radiofrequency ablation', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Disappearance of the nodules in follow up', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['radiofrequency', 'thyroid', 'nodule'], 'conditions': ['Thyroid Nodules']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. the presence of subjective symptoms (foreign body sensation, neck discomfort or pain, compressive symptom) or cosmetic problems;\n2. a poor surgical candidate or refusal to undergo surgery;\n3. fine-needle aspiration cytology and US findings that were compatible with a benign nodule;\n4. anxiety about a malignancy.\n\nExclusion Criteria:\n\n1. a nodule less than 5 mm in size;\n2. follicular neoplasm or malignancy on fine needle aspiration cytology (FNAC);\n3. a nodule with the sonographic criteria for a malignancy (taller than wide, marked hypoechoic, microcalcifications, ill-defined margins), although FNAC was a benign result;\n4. previous radiation or operation history to the head and neck; (5) previous sclerosing therapy.'}, 'identificationModule': {'nctId': 'NCT01750593', 'briefTitle': 'Radiofrequency Ablation in Thyroid Nodules', 'organization': {'class': 'OTHER', 'fullName': 'Bezmialem Vakif University'}, 'officialTitle': 'Efficacy of Radiofrequency Ablation in Thyroid Nodules', 'orgStudyIdInfo': {'id': 'yelizeminersoy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'radiofrequency ablation of thyroid nodule', 'description': 'Under ultrasonography the thyroid nodules will be ablated by radiofrequency ablation', 'interventionNames': ['Procedure: Radiofrequency ablation of the thyroid nodule']}], 'interventions': [{'name': 'Radiofrequency ablation of the thyroid nodule', 'type': 'PROCEDURE', 'description': 'Under USG control, the nodule will be ablated by radiofrequency with a needle that has an active tip of 1 cm.', 'armGroupLabels': ['radiofrequency ablation of thyroid nodule']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34308', 'city': 'Istanbul', 'state': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Erhan Aysan, Prof', 'role': 'CONTACT', 'email': 'erhanaysan@hotmail.com', 'phone': '902124531700', 'phoneExt': '4116'}, {'name': 'Yeliz Ersoy, Assoc. Prof', 'role': 'CONTACT', 'email': 'yelizemineersoy@yahoo.com', 'phone': '902124531700', 'phoneExt': '4506'}], 'facility': 'Bezmialem Vakif University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '34308', 'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Erhan Aysan, Prof. Dr.', 'role': 'CONTACT', 'email': 'erhanaysan@hotmail.com'}], 'facility': 'Bezmialem Vakif University medical Faculty', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'ERHAN AYSAN, PROF.', 'role': 'CONTACT', 'email': 'yelizemineersoy@yahoo.com', 'phone': '902124531700'}], 'facility': 'Bezmialem Vakif University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Erhan Aysan, Prof. Dr.', 'role': 'CONTACT', 'email': 'erhanaysan@hotmail.com'}, {'name': 'Yeliz Ersoy, Assoc.Prof', 'role': 'CONTACT', 'email': 'yelizemineersoy@yahoo.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bezmialem Vakif University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Yeliz Emine Ersoy', 'investigatorAffiliation': 'Bezmialem Vakif University'}}}}