Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-01-15 @ 8:46 PM
Study NCT ID:
NCT02491502
Status:
COMPLETED
Last Update Posted:
2021-10-12
First Post:
2015-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Benign Thyroid Nodules With FastScan HIFU
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': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-11', 'studyFirstSubmitDate': '2015-06-24', 'studyFirstSubmitQcDate': '2015-07-07', 'lastUpdatePostDateStruct': {'date': '2021-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with adverse events', 'timeFrame': '1 day post treatment'}, {'measure': 'Number of participants with adverse events', 'timeFrame': '3 days post treatment'}, {'measure': 'Number of participants with adverse events', 'timeFrame': '7 days post treatment'}, {'measure': 'Change in volume of the thyroid nodule compared to Baseline at 6 months', 'timeFrame': '6 months post treatment'}, {'measure': 'Change from Baseline Patient pain intensity score (100mm visual analog scale) at 1 day', 'timeFrame': '1 day post treatment'}, {'measure': 'Change from Baseline Patient pain intensity score (100mm visual analog scale) at 3 days', 'timeFrame': '3 days post treatment'}, {'measure': 'Change from Baseline Patient pain intensity score (100mm visual analog scale) at 7 days', 'timeFrame': '7 days post treatment'}, {'measure': 'Patient satisfaction questionnaire', 'timeFrame': '6 months post treatment'}], 'secondaryOutcomes': [{'measure': 'Number of patients with Absence of palpable lesion', 'timeFrame': '3 months post treatment'}, {'measure': 'Number of patients with Absence of palpable lesion', 'timeFrame': '6 months post treatment'}, {'measure': 'Patient Cosmetic evaluation measured by questionnaire', 'timeFrame': '6 months post treatment'}, {'measure': 'Investigator rated evaluation of the device', 'timeFrame': 'Post treatment Day 0'}, {'measure': 'Change from Baseline of gland vascularization at 3 months', 'timeFrame': '3 months post treatment'}, {'measure': 'Change from Baseline of gland vascularization at 6 months', 'timeFrame': '6 months post treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Benign Thyroid Nodules']}, 'descriptionModule': {'briefSummary': 'This study evaluates the efficacy of the HIFU for the treatment of benign thyroid nodules with the FastScan version using assessment of patient experience and adverse event reporting.', 'detailedDescription': 'Echopulse is specially designed, manufactured and CE marked for treating benign thyroid nodules. HIFU is a completely alternative to surgery which utilizes high-energy ultrasound to deliver a large amount of sound energy to a focal point to rapidly induce tissue heating to 85-90°C.This initiates tissue coagulation followed by tissue necrosis ablating the targeted area.\n\nIn a previous european feasibility study performed at 1 site (Bulgaria), 20 benign thyroid nodules were treated. The HIFU treatment was well tolerated and showed efficacy.'}, '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 (fine-needle aspiration biopsy) from the last 6 months\n 3. Normal serum calcitonin\n 4. No history of neck irradiation\n* Normal TSH (thyroid-stimulating hormone)\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) : predominantly solid\n* Patient has signed a written informed consent.\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 the assigned analgesia/anaesthesia.'}, 'identificationModule': {'nctId': 'NCT02491502', 'briefTitle': 'Treatment of Benign Thyroid Nodules With FastScan HIFU', 'organization': {'class': 'INDUSTRY', 'fullName': 'Theraclion'}, 'officialTitle': 'Treatment of Benign Thyroid Nodules With FastScan High Intensity Focused Ultrasound (HIFU)', 'orgStudyIdInfo': {'id': 'HIFU/BG/TN/FS/2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Echopulse', 'description': 'Echopulse HIFU', 'interventionNames': ['Device: Echopulse']}], 'interventions': [{'name': 'Echopulse', 'type': 'DEVICE', 'otherNames': ['Echopulse HIFU'], 'description': 'HIFU Under ultrasound guidance', 'armGroupLabels': ['Echopulse']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1431', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'University Hospital of Endocrinology USBALE', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}], 'overallOfficials': [{'name': 'Roussanka Kovatcheva, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'roussanka_kov@yahoo.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Theraclion', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}