Ignite Creation Date:
2025-12-24 @ 9:20 PM
Ignite Modification Date:
2026-01-26 @ 9:11 PM
Study NCT ID:
NCT02246504
Status:
COMPLETED
Last Update Posted:
2019-09-17
First Post:
2014-09-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registry - Use of a High Intensity Focused Ultrasound (HIFU) in Patients With Non-malignant Thyroid Nodules.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2017-03-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-13', 'studyFirstSubmitDate': '2014-09-16', 'studyFirstSubmitQcDate': '2014-09-19', 'lastUpdatePostDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change from baseline in thyroid nodule's volume", 'timeFrame': 'Month 6'}], 'secondaryOutcomes': [{'measure': "Change from baseline in thyroid nodule's structure and vascularisation", 'timeFrame': 'Month 6'}, {'measure': 'Number of participants with adverse events', 'timeFrame': 'D1, D7, M1, M3 and M6'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Non-malignant Thyroid Nodule']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate thyroid nodule's volume, structure and vascularisation changes following HIFU therapy assessed by ultrasonography", 'detailedDescription': 'HIFU treatment will be performed under conscious sedation under the supervision / responsibilities of an anesthetist.\n\nA maximum of 2 HIFU sessions per nodule will be performed per patient. The decision to retreat the patient will be taken at 1 month post-HIFU or later.\n\nFollow-up after HIFU treatment\n\nD1 after HIFU session:\n\n* Indirect laryngoscopy to check vocal cord mobility.\n\nD7 after HIFU session\n\n* Clinical examination (skin, local symptoms, oedema, voice….),\n* Ultrasonography and Power Doppler,\n\nM1 after HIFU session\n\n* Clinical examination (skin, local symptoms, oedema, voice….),\n* Ultrasonography and Power Doppler,\n\nM3 after HIFU session\n\n* Clinical examination (skin, local symptoms, oedema, voice….),\n* Ultrasonography and Power Doppler Decision for an additional HIFU course to improve volume reduction.\n\nIn case of a second HIFU session D7b, M1b and M3b, M6b, M9b, M12b, M18b, M24b and M36b will be performed\n\nM6 after last HIFU session\n\n* Clinical examination (skin, local symptoms, oedema, voice….),\n* Ultrasonography and Power Doppler\n* TSH\n* Free T4\n* Antithyroid peroxidase antibodies\n* Calcemia and PTH (in case of bilateral treatment or in case previous thyroid surgery)\n\nM9 after HIFU session\n\n* Clinical examination (skin, local symptoms, oedema, voice….),\n* Ultrasonography and Power Doppler\n\nM12 after last HIFU session\n\n* Clinical examination (skin, local symptoms, oedema, voice….),\n* Ultrasonography and Power Doppler\n* TSH\n* Free T4\n* Antithyroid peroxidase antibodies\n* Calcemia and PTH (in case of bilateral treatment or in case previous thyroid surgery)\n\nM18, M24, M36 after HIFU session\n\n* Clinical examination (skin, local symptoms, oedema, voice….),\n* Ultrasonography and Power Doppler'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patient 18 years or older.\n* Patient presenting with at least one thyroid nodule with no signs of malignancy:\n\n 1. Non suspect clinically and at ultrasonography imaging\n 2. Benign cytological diagnosis at FNAB from the last 6 months\n 3. Normal serum calcitonin\n 4. No history of neck irradiation\n* Normal TSH.\n* Targeted nodule accessible and eligible to HIFU\n* Absence of abnormal vocal cord mobility at laryngoscopy.\n* Nodule diameter ≥ 10mm measured by ultrasound.\n* Composition of the targeted nodule(s) : no more than 30% cystic\n\nExclusion Criteria:\n\n* Head and/or neck disease that prevents hyperextension of neck.\n* Known history of thyroid cancer or other neoplasias in the neck region.\n* History of neck irradiation.\n* Macrocalcification inducing a shadow in the thyroid significant enough to preclude the HIFU treatment\n* Posterior position of the nodule if the thickness of the nodule is \\<15mm\n* Pregnant or lactating woman\n* Any contraindication to IV neurolept analgesia.'}, 'identificationModule': {'nctId': 'NCT02246504', 'briefTitle': 'Registry - Use of a High Intensity Focused Ultrasound (HIFU) in Patients With Non-malignant Thyroid Nodules.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Theraclion'}, 'officialTitle': 'Registry - Use of a High Intensity Focused Ultrasound (HIFU) in Patients With Non-malignant Thyroid Nodules.', 'orgStudyIdInfo': {'id': 'HIFU/BG/NT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HIFU treatment', 'description': 'use of HIFU treatment in patients with non-malignant thyroid nodules', 'interventionNames': ['Device: HIFU treatment']}], 'interventions': [{'name': 'HIFU treatment', 'type': 'DEVICE', 'armGroupLabels': ['HIFU treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14031', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Clinic of thyroid and metabolite bone disease of the Acad. of Ivan Penchev UDHATE - 2, Zdrave street', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}], 'overallOfficials': [{'name': 'Roussanka Kovatcheva, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Theraclion', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}