[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611191":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":37,"studyPopulation":38,"armGroups":39,"interventions":45,"overallOfficials":33,"centralContacts":54,"locations":63,"responsibleParty":114,"collaborators":116,"id":121,"slug":33,"hasResults":122,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":122,"sex":128,"minAge":129,"maxAge":33,"enrollmentInfo":130,"targetDuration":133,"studyType":134,"phases":33,"briefSummary":135,"conditions":136,"keywords":138,"overallStatus":86,"whyStopped":33,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},{"fullName":5,"class":6},"University Hospital, Ghent","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":33},[9],{"measure":10,"description":11,"timeFrame":12},"Health related Quality Of Life (HRQoL)","HRQoL will be assessed by the change in Thyroid-Related Patient-Reported Outcome 39 (ThyPRO-39) score from baseline to 1-year follow-up. The ThyPRO-39 is a thyroid-specific quality of life instrument covering 13 domains of QoL validated for patients with benign thyroid disease. The ThyPRO-39 includes scales assessing the following: goiter symptoms, eye symptoms, hyperthyroid symptoms, hypothyroid symptoms, tiredness, cognitive complaints, anxiety, depressivity, emotional susceptibility, impaired social life, impaired daily life, appearance, and overall QoL. Each item is rated on a Likert scale (0-4) from 0 = \"no symptoms\u002Fproblems\" to 4 = \"severe symptoms\u002Fproblems.\" Scores are then transformed to yield 13 0-100 scales, where a higher score indicates worse health-related QoL","From baseline (before treatment) to 12 months after the radiofrequency ablation procedure, with assessments at baseline, 1 month, 3 months, 6 months, and 12 months",[14,18,21,24,27,30],{"measure":15,"description":16,"timeFrame":17},"Symptom score","Registered on a Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates \"no symptoms\" and 10 indicates \"worst imaginable symptoms\".","From baseline (before treatment) to 12 months after the radiofrequency ablation procedure, with assessments at baseline, 1 month, 3 months, 6 months, and 12 months.",{"measure":19,"description":20,"timeFrame":17},"Cosmetic score","Assessed during physical examination; ranging from 1 to 4, where 1 graded as no palpable mass, 2 graded as a palpable mass without cosmetic issue, 3 graded as a cosmetic problem on swallowing, and 4 as a readily detected cosmetic problem.",{"measure":22,"description":23,"timeFrame":17},"Number of Participants with Treatment-Related Adverse Events","Safety will be measured based on the presence of minor or major complications. Major and minor complications are those defined by the Society of Interventional Radiology.",{"measure":25,"description":26,"timeFrame":17},"Volume Reduction Rate (VRR)","Calculated as VRR (%) = (initial volume - final volume) ÷ initial volume × 100",{"measure":28,"description":29,"timeFrame":17},"Technical efficacy","Defined as a VRR ≥50%. Regrowth is defined as an increase in nodule volume to at least 150% of the minimum recorded volume during the follow-up period.",{"measure":31,"description":32,"timeFrame":17},"Thyroid function","Evaluation of thyroid function, including serum TSH, free T4 (FT4), and free T3 (FT3) levels",null,{"allocation":33,"interventionModel":33,"interventionModelDescription":33,"primaryPurpose":33,"observationalModel":35,"timePerspective":36,"maskingInfo":33},"CASE_ONLY","PROSPECTIVE","Benign thyroid nodules are highly prevalent in the adult population. While most remain asymptomatic, some patients experience compressive symptoms, cosmetic concerns, or hyperthyroidism due to autonomously functioning nodules. Standard therapy is hemithyroidectomy or total thyroidectomy, which is effective but associated with risks such as hypothyroidism, nerve injury, visible scarring, and increased health care costs. As a result, minimally invasive, nonsurgical alternatives are being actively investigated.\n\nRadiofrequency ablation (RFA) is a percutaneous thermoablation technique performed under ultrasound guidance using a cooled electrode needle. Heat generated at the electrode tip induces localized necrosis within the target nodule, leading to progressive shrinkage while sparing surrounding thyroid tissue. In most cases, the procedure is carried out under local anesthesia in an outpatient setting, with an average duration of 15-40 minutes. The \"moving shot\" technique is typically employed, allowing precise ablation of large nodules in multiple overlapping steps.\n\nInternational guidelines from the European Thyroid Association (ETA) and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) recommend RFA as an alternative for patients with benign thyroid nodules who present with compressive symptoms, cosmetic complaints, or autonomously functioning thyroid nodules not suitable for surgery or radioactive iodine.\n\nThis multicenter prospective observational study will investigate the clinical effectiveness and safety of RFA in routine practice. The primary outcome is health-related quality of life (HRQoL), assessed by the validated ThyPRO-39 instrument. Secondary outcomes include technical efficacy (≥50% volume reduction rate), symptom and cosmetic improvement, stability of thyroid function, and safety endpoints based on the CIRSE classification of complications.\n\nParticipants will undergo standardized baseline evaluation including ultrasound, cytology, and thyroid function testing. Follow-up visits are scheduled at 1, 3, 6, and 12 months, with systematic assessments of nodule characteristics, laboratory values, patient-reported outcomes, and complications. Technical success and regrowth will be defined according to internationally accepted thresholds.\n\nBy collecting prospective multicenter data, this study aims to generate high-quality evidence on the role of RFA in the treatment of benign thyroid nodules. The results are expected to strengthen the scientific and economic case for adopting RFA as a reimbursable, minimally invasive therapy in clinical practice, while contributing to the long-term body of literature on patient-centered outcomes in thyroid disease.","Study participants will be selected from the following Belgian hospitals: Ghent University Hospital, University Hospital Leuven, AZ Sint Jan Brugge.",[40],{"label":41,"type":33,"description":42,"interventionNames":43},"Benign thyriod nodules","Subjects with symptomatic benign thyroid nodules with compressive\u002Fcosmetic complaints OR autonomously functioning thyroid nodules with subclinical hyperthyreosis or thyrotoxicosis proven on scintigraphy.",[44],"Device: Percutaneous radiofrequency ablation",[46],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":51},"DEVICE","Percutaneous radiofrequency ablation","RFA uses an electric field, produced by a radiofrequency generator connected to an internally cooled electrode needle, leading to frictional agitation at the ionic level and to heat generation (Joule effect). The electrode is introduced under US guidance into the target nodule, and a continuous repositioning of the applicator (\"moving shot\" or \"multiple overlapping shot\" technique). The localized heating causes necrosis and shrinkage of the thyroid nodule without damaging surrounding tissues. The appearance of hyperechoic signals close to the electrode tip indicates the development of tissue changes and air formation, while a steep rise in tissue impedance demonstrates the achievement of tissue necrosis",[41],[52,53],"RFA","radiofrequency ablation",[55,60],{"name":56,"role":57,"phone":58,"phoneExt":33,"email":59},"Charlotte Harth, MD","CONTACT","+32 9 332 0450","studies.vinrad@uzgent.be",{"name":61,"role":57,"phone":58,"phoneExt":33,"email":62},"Lien Van Cauwenberghe, MSc","lien.vancauwenberghe@uzgent.be",[64,84,98],{"facility":65,"status":66,"city":67,"state":33,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"AZ Sint-Jan Brugge","NOT_YET_RECRUITING","Bruges","8000","Belgium","BE",{"type":72,"coordinates":73},"Point",[74,75],3.22424,51.20892,{"lat":75,"lon":74},[78,82],{"name":79,"role":57,"phone":80,"phoneExt":33,"email":81},"Andries Van Holsbeeck, MD","+32 50 45 21 01","rx.afspraken@azsintjan.be",{"name":79,"role":83,"phone":33,"phoneExt":33,"email":33},"PRINCIPAL_INVESTIGATOR",{"facility":85,"status":86,"city":87,"state":33,"zip":88,"country":69,"countryCode":70,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"UZ Gent","RECRUITING","Ghent","9000",{"type":72,"coordinates":90},[91,92],3.71667,51.05,{"lat":92,"lon":91},[95,97],{"name":56,"role":57,"phone":58,"phoneExt":33,"email":96},"charlotte.harth@uzgent.be",{"name":56,"role":83,"phone":33,"phoneExt":33,"email":33},{"facility":99,"status":66,"city":100,"state":33,"zip":101,"country":69,"countryCode":70,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"UZ Leuven","Leuven","3000",{"type":72,"coordinates":103},[104,105],4.70093,50.87959,{"lat":105,"lon":104},[108,112],{"name":109,"role":57,"phone":110,"phoneExt":33,"email":111},"Geert Maleux","+32 16 34 36 60","radiologie@uzleuven.be",{"name":113,"role":83,"phone":33,"phoneExt":33,"email":33},"Geert Maleux, PhD",{"type":115,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR",[117,119],{"name":118,"class":6},"Universitaire Ziekenhuizen KU Leuven",{"name":120,"class":6},"AZ Sint-Jan AV","100611191",false,"NCT07237373","Percutaneous Thermo-ablation for the Treatment of Benign Thyroid Nodules","Percutaneous Thermo-ablation for the Treatment of Benign Thyroid Nodules: a Prospective Multicentric Study","BIRRO-TA","Inclusion Criteria:\n\n* \\> 18 years old\n* 'Eastern Cooperative Oncology Group' (ECOG) performance status of 0 or 1\n* Symptomatic benign thyroid nodules with compressive\u002Fcosmetic complaints OR autonomously functioning thyroid nodules with subclinical hyperthyreosis or thyrotoxicosis proven on scintigraphy.\n* No cutoff in nodule size.\n* Solid component \\> 20%, and benign cytology (Bethesda II) in 1 (EUTIRADS 3) or 2 (EUTIRADS 4) separate cytological assessments. In the case of a proven \"hot\" nodule on scintigraphy, no biopsy is required.\n\nExclusion Criteria:\n\n* \\\u003C18y\n* Purely cystic nodule\n* Severe comorbidity which limits the further life expectancy of the patient to \\\u003C 2 years (opinion of the physician)\n* Malignancies \\\u003C2 years ago except for non-melanoma skin cancer and non-muscle invasive bladder cancer.\n* Lack of compliance\n* Malignant or suspicious thyroid nodules or nodules that are confluent in a compressive lobar mass\n* Contralateral vocal cord paralysis\n* Anticoagulant therapy that could not be suspended\n* Unresolvable coagulation disorders\n* Absence of consent of the patient","ALL","18 Years",{"count":131,"type":132},50,"ESTIMATED","12 Months","OBSERVATIONAL","The goal of this observational study is to learn if radiofrequency ablation (RFA), a minimally invasive thermoablation technique, can safely reduce symptoms and improve quality of life in adults with symptomatic benign thyroid nodules or autonomously functioning thyroid nodules.\n\nThe main questions it aims to answer are:\n\n* Does RFA improve health-related quality of life (HRQoL) as measured by the ThyPRO-39 questionnaire?\n* Does RFA effectively reduce nodule volume and related symptoms (compressive or cosmetic)?\n\nParticipants will:\n\n* Undergo a radiofrequency ablation procedure of the thyroid nodule performed under ultrasound guidance in an outpatient setting.\n* Complete quality of life questionnaires (ThyPRO-39) before treatment and at follow-up visits.\n\nAttend follow-up visits at 1, 3, 6, and 12 months with:\n\n* Ultrasound assessments of the thyroid nodule\n* Symptom and cosmetic scoring\n* Blood tests to monitor thyroid function\n* Safety checks for possible complications",[137],"Benign Thyroid Nodule",[139,53,140,141],"benign thyroid nodule","interventional radiology","percutaneous thermoablation","2026-04-23",{"date":144,"type":145},"2026-04-29","ACTUAL",{"date":147,"type":145},"2026-03-03",{"date":149,"type":132},"2031-04-01",{"name":5,"class":6},3]