Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-02-20 @ 10:45 PM
Study NCT ID:
NCT03328260
Status:
COMPLETED
Last Update Posted:
2020-01-03
First Post:
2017-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Intensity Focused Ultrasound in Uterine Myoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047708', 'term': 'Myofibroma'}], 'ancestors': [{'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-01', 'studyFirstSubmitDate': '2017-10-29', 'studyFirstSubmitQcDate': '2017-10-29', 'lastUpdatePostDateStruct': {'date': '2020-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Non perfused volume', 'timeFrame': 'treatment day', 'description': 'Non perfused volume in myoma immediately after ablation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Uterine Leiomyoma']}, 'referencesModule': {'references': [{'pmid': '33259999', 'type': 'DERIVED', 'citation': 'Lee JY, Kim K, Hwang SI, Lee M, Son K, Kim D, Kim S, Kim YB. Efficacy and safety of transvaginal high-intensity focused ultrasound therapy in women with symptomatic uterine leiomyomas: A clinical trial. Eur J Obstet Gynecol Reprod Biol. 2021 Jan;256:302-307. doi: 10.1016/j.ejogrb.2020.11.049. Epub 2020 Nov 17.'}]}, 'descriptionModule': {'briefSummary': 'Aim to evaluate the efficacy of safety of newly developed, high intensity focused ultrasound device in women with symptomatic uterine leiomyoma'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Premenopausal (FSH \\< 40 IU/L)\n* Symptomatic uterine fibroids\n* Willing to contracept during study period\n\nExclusion Criteria:\n\n* Pregnant or willing to be pregnant in future\n* Cancer in female reproductive organ is suspected or diagnosed\n* Inflammation in female reproductive organ\n* Poorly controlled systemic disease\n* Hematocrit \\< 25%\n* Glomerular filtration rate(GFR) \\<= 30ml/min\n* Cannot tolerate contrast-enhanced MR or Contrast-enhanced ultrasound(CEUS)\n* Cannot lie down\n* Previous treatment for leiomyoma, any of ① myolysis, ② myomectomy within 1 year, ③ hormonal therapy longer than 7 days within 4 weeks\n* Cannot count the number or measure volume of leiomyoma using MRI\n* Leiomyomas are inadequate (location, volume, number) for intervention\n* Diameter of leiomyoma is over 5 cm\n* Leiomyoma is not enhanced\n* Lactating women\n* Cannot communicate properly\n* Participating or have participated in other trials within 30 days'}, 'identificationModule': {'nctId': 'NCT03328260', 'briefTitle': 'High Intensity Focused Ultrasound in Uterine Myoma', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Prospective, Muti-institute, Single Arm, Confirmative Trial Evaluating Efficacy and Safety of High Intensity Focused Ultrasound Device (RODIN) in Women With Symptomatic Uterine Leiomyoma', 'orgStudyIdInfo': {'id': 'APM-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'interventionNames': ['Device: HIFU']}], 'interventions': [{'name': 'HIFU', 'type': 'DEVICE', 'description': 'Transvaginal high intensity focused ultrasound to ablate uterine myoma', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '463707', 'city': 'Seongnam-si', 'state': 'Gyenggi DO', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'ALPINION Medical Systems', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}