Ignite Creation Date:
2025-12-24 @ 8:01 PM
Ignite Modification Date:
2026-01-01 @ 4:38 PM
Study NCT ID:
NCT02914704
Status:
RECRUITING
Last Update Posted:
2019-04-29
First Post:
2016-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Benign Uterine Disorders Using High Intensity Focused Ultrasound (MR-HIFU)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007889', 'term': 'Leiomyoma'}, {'id': 'D062788', 'term': 'Adenomyosis'}], 'ancestors': [{'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-26', 'studyFirstSubmitDate': '2016-01-05', 'studyFirstSubmitQcDate': '2016-09-22', 'lastUpdatePostDateStruct': {'date': '2019-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Technical efficacy of HIFU for treatment of uterine fibroids as assessed by a change in the Symptom Severity Score', 'timeFrame': '12 months after treatment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False}, 'conditionsModule': {'conditions': ['Uterine Fibroids', 'Adenomyosis']}, 'descriptionModule': {'briefSummary': "MRI-guided high intensity focused ultrasound (MRI-HIFU) has been proven to be a safe and effective method in treating uterine fibroids and also adenomyosis. However, systematic studies on the effect of this treatment on factors affecting fertility are still lacking. Also quite little is known about body's systemic response to MRI-HIFU. Thus the aim of this study is to obtain more information on the systemic response of the body to the HIFU-treatment when treating non-malignant disease as well as to study the effect of MRI-HIFU on factors affecting fertility. Women with symptomatic uterine fibroids or adenomyosis suitable for MRI-HIFU treatment are recruited to this study. The severity of symptoms will be assessed with UFS-QoL and the same questionnaire will also be used in follow-up 3, 6 and 12 months after treatment. Blood, urine and endometrium samples will be collected pre- and postoperatively and during follow-up 3, 6 and 12 months after the treatment. From these samples detailed analysis of the immunological, inflammatory and hormonal response will be performed. As this is the first study in Finland of treating uterine fibroids and adenomyosis using MRI-HIFU, also a report about the efficacy of the MRI-HIFU in treating the uterine disorders will be published, and a key tool in assessing the treatment outcome would be the UFS-QoL questionnaire.\n\nAlso new methods for improving patient selection as well as treatment efficacy will be evaluated in this study."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\< 35\n* Premenopausal\n* Uterine size \\<20 gw\n* Willingness to participate to the research\n* Uterine fibroids with typical symptoms\n* Maximum of 4 treated fibroids\n* Dominant fibroid \\>2.5cm\n* \\>50% of the fibroid is treatable\n\nExclusion criteria\n\n* Unspecified pelvic tumours or ovarian masses, PID\n* Major corrective surgery to uterus (simple myomectomy excluded)\n* Major uterine anomalies\n* Unability to calculate the volume of uterine fibroids\n* Marked uterine calcification\n* Marked scarring of the lower abdomen\n* Suspicion of malignancy\n* Marked general health problem contraindicating MRI\n* Claustrophobia'}, 'identificationModule': {'nctId': 'NCT02914704', 'briefTitle': 'Treatment of Benign Uterine Disorders Using High Intensity Focused Ultrasound (MR-HIFU)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Turku University Hospital'}, 'officialTitle': 'Treatment of Benign Uterine Disorders Using High Intensity Focused Ultrasound (MR-HIFU)', 'orgStudyIdInfo': {'id': 'GYN-HIFU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients treated with MRI-HIFU', 'interventionNames': ['Device: MRI-HIFU']}], 'interventions': [{'name': 'MRI-HIFU', 'type': 'DEVICE', 'description': 'Treatment of uterine fibroids with MRI-HIFU', 'armGroupLabels': ['Patients treated with MRI-HIFU']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20521', 'city': 'Turku', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Kirsi M Joronen, MD PhD', 'role': 'CONTACT', 'email': 'kirsi.joronen@tyks.fi', 'phone': '+35823130561'}], 'facility': 'Turku University Hospital', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}], 'centralContacts': [{'name': 'Kirsi M Joronen, PhD', 'role': 'CONTACT', 'email': 'kirsi.joronen@tyks.fi'}], 'overallOfficials': [{'name': 'Kirsi M Joronen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Turku University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Turku University Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}