Ignite Creation Date:
2025-12-24 @ 11:58 AM
Ignite Modification Date:
2025-12-25 @ 11:56 AM
Study NCT ID:
NCT01979861
Status:
UNKNOWN
Last Update Posted:
2016-07-12
First Post:
2013-11-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety & Effectiveness Study of AEGEA Vapor System to Treat Excessive Uterine Bleeding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2018-02-05', 'releaseDate': '2018-01-08'}], 'estimatedResultsFirstSubmitDate': '2018-01-08'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008595', 'term': 'Menorrhagia'}], 'ancestors': [{'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'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'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008599', 'term': 'Menstruation Disturbances'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 230}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-07-08', 'studyFirstSubmitDate': '2013-11-04', 'studyFirstSubmitQcDate': '2013-11-07', 'lastUpdatePostDateStruct': {'date': '2016-07-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Effectiveness Endpoint', 'timeFrame': '12 months', 'description': 'Reduction of menstrual blood loss'}], 'secondaryOutcomes': [{'measure': 'Secondary Effectiveness Endpoint', 'timeFrame': '12 months', 'description': 'Quality of Life'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Endometrial ablation with vapor'], 'conditions': ['Menorrhagia']}, 'referencesModule': {'references': [{'pmid': '33603496', 'type': 'DERIVED', 'citation': 'Leyland N, Harris M. Water Vapor Endometrial Ablation for Heavy Menstrual Bleeding: 36-Month Follow-Up of a Prospective, Multicenter Pivotal Clinical Trial. Int J Womens Health. 2021 Feb 10;13:169-176. doi: 10.2147/IJWH.S279864. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if the AEGEA Vapor System for endometrial ablation is safe and effective for reducing menstrual blood loss in women with excessive uterine bleeding (menorrhagia)', 'detailedDescription': 'This is a single-arm, multi-center study with three years of follow-up.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female subject from (and including) age 30 to 50 years\n* Self-reported history of heavy menstrual bleeding in at least 3 of the last 6 months\n* Predictable cyclic menstrual cycles over past 6 months\n* Excessive uterine bleeding\n* Premenopausal at enrollment\n* Normal PAP\n* Normal endometrial biopsy\n* Willing to use reliable contraception\n* Not currently taking hormonal medication\n* Agree to use sponsor provided catamenial product (sanitary pads/tampons)\n\nExclusion Criteria:\n\n* Pregnant\n* Desires future childbearing\n* Presence of an IUD\n* Previous endometrial ablation procedure\n* Evidence of STI\n* Evidence of PID\n* Active infection of genitals, vagina, cervix, uterus or urinary tract\n* Active endometritis\n* Active bacteremia, sepsis or other active systemic infection\n* Gynecologic malignancy\n* Endometrial hyperplasia\n* Known clotting defects or bleeding disorders\n* On anticoagulant therapy\n* Hemoglobin \\<8gm/dl\n* Prior uterine surgery\n* Currently on medication that could thin myometrial muscle\n* Severe dysmenorrhea, secondary to adenomyosis\n* Abnormal uterine cavity\n* Hydrosalpinx\n* Uterine length \\<6cm or \\>12cm\n* Currently in other clinical trial'}, 'identificationModule': {'nctId': 'NCT01979861', 'briefTitle': 'Safety & Effectiveness Study of AEGEA Vapor System to Treat Excessive Uterine Bleeding', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aegea Medical, Inc.'}, 'officialTitle': 'A Prospective, Multicenter, Clinical Trial to Evaluate the Safety and Effectiveness of the AEGEA Vapor System for the Treatment of Excessive Uterine Bleeding', 'orgStudyIdInfo': {'id': 'SE-3000'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'vapor endometrial ablation', 'description': 'endometrial ablation using the AEGEA Vapor System', 'interventionNames': ['Device: AEGEA Vapor System(TM)']}], 'interventions': [{'name': 'AEGEA Vapor System(TM)', 'type': 'DEVICE', 'description': 'vapor endometrial ablation', 'armGroupLabels': ['vapor endometrial ablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06051', 'city': 'New Britain', 'state': 'Connecticut', 'country': 'United States', 'facility': "Center for Fertility and Women's Health", 'geoPoint': {'lat': 41.66121, 'lon': -72.77954}}, {'zip': '32801', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Associates of Orlando, LLC', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33414', 'city': 'Wellington', 'state': 'Florida', 'country': 'United States', 'facility': 'Visions Clinical Research', 'geoPoint': {'lat': 26.65868, 'lon': -80.24144}}, {'zip': '83404', 'city': 'Idaho Falls', 'state': 'Idaho', 'country': 'United States', 'facility': 'Rosemark WomenCares Specialists', 'geoPoint': {'lat': 43.46658, 'lon': -112.03414}}, {'zip': '60173', 'city': 'Naperville', 'state': 'Illinois', 'country': 'United States', 'facility': 'The Advanced Gynecologic Surgery Institute', 'geoPoint': {'lat': 41.78586, 'lon': -88.14729}}, {'zip': '47630', 'city': 'Newburgh', 'state': 'Indiana', 'country': 'United States', 'facility': 'Basinksi, LLC', 'geoPoint': {'lat': 37.94449, 'lon': -87.40529}}, {'zip': '55435', 'city': 'Edina', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota Gynecology & Surgery', 'geoPoint': {'lat': 44.88969, 'lon': -93.34995}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Mercy Hospital', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '27713', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': "Carolina Women's Research and Wellness Center/OB-GYN", 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '37404', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Chattanooga Medical Research, LLC', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor All Saints', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': 'L8N 3Z5', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Department of Obstetrics and Gynecology', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'city': 'Monterrey', 'state': 'N.l.', 'country': 'Mexico', 'facility': 'Hospital Universitario de la Universidad Autonoma de Nuevo Leon', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'zip': '8025 AB', 'city': 'Zwolle', 'state': 'Overijissel', 'country': 'Netherlands', 'facility': 'Isala Klinieken', 'geoPoint': {'lat': 52.5125, 'lon': 6.09444}}], 'overallOfficials': [{'name': 'Mark Levie, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montefiore Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aegea Medical, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2018-01-08', 'type': 'RELEASE'}, {'date': '2018-02-05', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Aegea Medical, Inc.'}}}}