Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2026-01-26 @ 6:10 PM
Study NCT ID:
NCT00574418
Status:
UNKNOWN
Last Update Posted:
2009-01-05
First Post:
2007-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Far Infrared Radiation Treatment for Uterine Fibroids
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007889', 'term': 'Leiomyoma'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}], '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': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2008-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-01-02', 'studyFirstSubmitDate': '2007-12-12', 'studyFirstSubmitQcDate': '2007-12-14', 'lastUpdatePostDateStruct': {'date': '2009-01-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary end point is to determine the therapeutic effects of far infrared radiation on uterine fibroids', 'timeFrame': '2 years and 9 months'}], 'secondaryOutcomes': [{'measure': 'The secondary end point of the study is to evaluate the therapeutic effects of far infrared radiation on other related uterine conditions, for example, bleeding.', 'timeFrame': 'Two years and nine months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Fibroid Tumor', 'Fibroid Uterus', 'Fibroids, Uterine', 'Fibromyoma', 'Uterine Neoplasms'], 'conditions': ['Leiomyoma']}, 'descriptionModule': {'briefSummary': 'A preliminary study to determine the efficacy of using energy specific far infrared (FIR) radiation for the treatment of uterine fibroids.', 'detailedDescription': 'Uterine fibroids are the most common neoplasms of the female pelvis. These benign tumors are generally oval in shape and often highly vascular. On MR imaging exams, uterine fibroids are easily identifiable. They occur in 20-25% of women of reproductive age and can cause a variety of problems generally described as either bleeding or mass effects from the fibroid.\n\nWe are postulating that energy specific electromagnetic radiation of the uterus will shrink the benign tumors.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women age 18 or older with symptomatic fibroids\n\nExclusion Criteria:\n\n* Women who are pregnant, as confirmed by serum test at time of screening, or urine pregnancy test on the day of treatment\n* Metallic implants that are incompatible with MRI or ultrasound\n* Known intolerance to the MRI contrast agent (e.g. Gadolinium)'}, 'identificationModule': {'nctId': 'NCT00574418', 'briefTitle': 'Far Infrared Radiation Treatment for Uterine Fibroids', 'organization': {'class': 'OTHER', 'fullName': 'GAAD Medical Research Institute Inc.'}, 'officialTitle': 'Phase 1 Study to Evaluate the Efficacy of Using Energy Specific Far Infrared Radiation Treatment for Uterine Fibroids', 'orgStudyIdInfo': {'id': 'GAAD-UF-CTP1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'interventionNames': ['Radiation: Far Infrared Radiation (5μm to 20μm wavelength)']}], 'interventions': [{'name': 'Far Infrared Radiation (5μm to 20μm wavelength)', 'type': 'RADIATION', 'otherNames': ['Far infrared radiation'], 'description': 'Far Infrared Radiation (5μm to 20μm wavelength) for 30 to 40 minutes during each session.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M4V 1L5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Centre for Incurable Diseases', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Ken B Nedd, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'GAAD Medical Research Institute Inc.'}, {'name': 'Kwasi Donyina, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GAAD Medical Research Institute Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GAAD Medical Research Institute Inc.', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Kwasi Donyina/Founder & President', 'oldOrganization': 'GAAD Medical Research Institute Inc.'}}}}