Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2026-02-03 @ 10:45 AM
Study NCT ID:
NCT02035332
Status:
COMPLETED
Last Update Posted:
2015-10-23
First Post:
2014-01-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Two-Phase Clinical Study of the Minerva AURORA Ablation System
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'eugenes@minervasurgical.com', 'phone': '(1) 650-284-3500', 'title': 'Dr. Eugene Skalnyi, VP Medical Affairs', 'organization': 'Minerva Surgical, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Aurora Treatment Arm', 'description': 'Endometrial Ablation\n\nAurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System', 'otherNumAtRisk': 21, 'otherNumAffected': 13, 'seriousNumAtRisk': 21, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anesthesia Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pelvic Cramping (non-specific)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain-occasional in middle-back', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'pregnancy- empty sac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Surgery for Heart Valve Replacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Reduction in Menstrual Blood Loss to Normal Levels at 12-months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aurora Treatment Arm', 'description': 'Endometrial Ablation\n\nAurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 Months', 'description': 'Number of subjects in whom menstrual blood loss was reduced to normal or below normal levels at 12 months, as measured by a pictorial blood loss assessment chart (PBLAC) score of \\<=75. A score of 0 represents no bleeding.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Protocol Intent-to-treat population (all subjects in whom the experimental device was attempted to be placed.)'}, {'type': 'SECONDARY', 'title': 'Procedure Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aurora Treatment Arm', 'description': 'Endometrial Ablation\n\nAurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System'}], 'classes': [{'categories': [{'measurements': [{'value': '5.2', 'spread': '2.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day of procedure', 'description': 'Procedure time defined as time from insertion of the Disposable Handpiece to the time of removal.', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects completing treatment'}, {'type': 'POST_HOC', 'title': 'Subjects With Amenorrhea at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aurora Treatment Arm', 'description': 'Endometrial Ablation\n\nAurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 Months', 'description': 'Amenorrhea at 12 Months- Number of Subjects experiencing no menstrual bleeding', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Protocol Intent-to-treat'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aurora Treatment Arm', 'description': 'Endometrial Ablation\n\nAurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Treatment Attempted', 'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'Treated', 'achievements': [{'comment': 'Treatment Completed', 'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed 12 Month Follow-up', 'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Procedure Aborted due to Uterine Width', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Subjects were enrolled in the clinical trial at 3 investigational sites in Hungary from May 2011 until October 2011.', 'preAssignmentDetails': '23 subjects enrolled: 2 subjects excluded based on pre-procedure hysteroscopy findings and did not receive treatment, in 1 subject treatment was attempted but procedure was aborted due to the width of the uterus, the remaining 20 subjects completed study treatment. The protocol ITT population included all subjects in whom treatment was attempted.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Aurora Treatment Arm', 'description': 'Endometrial Ablation\n\nAurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.9', 'spread': '3.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Hungary', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'PBLAC Score (assessment of menstrual blood loss)', 'classes': [{'categories': [{'measurements': [{'value': '419.2', 'spread': '152.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Pictorial Blood Loss Assessment Chart (PBLAC) is a tool used to assess menstrual blood loss. The PBLAC score takes into account the number of menstrual pads and tampons used as well as amount of saturation. A score of 0 represents no bleeding. Although the PBLAC score does not yield an exact measure of blood loss, it has been found to correlate well with menstrual blood volume. A score greater than 100 is correlated with a blood loss of at least 80 mL.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Enrolled Subjects'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'dispFirstSubmitDate': '2014-08-20', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-23', 'studyFirstSubmitDate': '2014-01-10', 'dispFirstSubmitQcDate': '2014-08-20', 'resultsFirstSubmitDate': '2015-08-21', 'studyFirstSubmitQcDate': '2014-01-10', 'dispFirstPostDateStruct': {'date': '2014-08-22', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-10-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-09-23', 'studyFirstPostDateStruct': {'date': '2014-01-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-10-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in Menstrual Blood Loss to Normal Levels at 12-months', 'timeFrame': '12 Months', 'description': 'Number of subjects in whom menstrual blood loss was reduced to normal or below normal levels at 12 months, as measured by a pictorial blood loss assessment chart (PBLAC) score of \\<=75. A score of 0 represents no bleeding.'}], 'secondaryOutcomes': [{'measure': 'Procedure Time', 'timeFrame': 'Day of procedure', 'description': 'Procedure time defined as time from insertion of the Disposable Handpiece to the time of removal.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Excessive Uterine Bleeding', 'Menorrhagia', 'Endometrial Ablation'], 'conditions': ['Menorrhagia Due to Benign Causes']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the use of the Aurora Ablation System in reducing menstrual blood loss at 12 months post-treatment. The occurrence of adverse events will be assessed along with an assessment of the reduction of uterine bleeding as measured by a pictorial blood loss assessment chart (PBLAC) or menstrual diary.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Refractory menorrhagia with no definable organic cause (abnormal uterine bleeding)\n2. Female subject from age 35 to 50 years\n3. Uterine sound measurement of 6.0cm to 10.0cm (external os to internal fundus)\n4. A minimum PBLAC score of \\>150 for 3 months prior to study enrollment; OR, A minimum PBLAC score \\>150 for one month for women who either\n\n 1. had at least 3 prior months documented failed medical therapy; or\n 2. had a contraindication to medical therapy; or\n 3. refused medical therapy\n5. Premenopausal at enrollment as determined by FSH measurement ≤ 40 IU/ml\n6. Not pregnant and no desire to conceive at any time\n7. Patient agrees not to use hormonal contraception or any other medical intervention for bleeding during the study\n8. Able to provide written informed consent using a form that has been approved by the reviewing IRB/EC\n9. Subject agrees to follow-up exams and data collection, including ability to accurately use menstrual diaries\n10. Subject who is literate or demonstrates an understanding on how to use menstrual diaries\n\nExclusion Criteria:\n\n1. Pregnancy or subject with a desire to conceive\n2. Complex endometrial hyperplasia as confirmed by histology\n3. Presence of active endometritis\n4. Active pelvic inflammatory disease\n5. Active sexually transmitted disease (STD)\n6. Presence of bacteremia, sepsis, or other active systemic infection\n7. Active infection of the genitals, vagina, cervix, uterus or urinary tract at the time of the procedure\n8. Known/suspected gynecological malignancy within the past 5 years\n9. Known clotting defects or bleeding disorders\n10. Untreated/unevaluated cervical dysplasia\n11. Known/suspected abdominal/pelvic cancer\n12. Prior uterine surgery (except low segment cesarean section) that interrupts the integrity of the uterine wall (e.g., transmural myomectomy or classical cesarean section)\n13. Previous endometrial ablation procedure\n14. Currently on medications that could thin the myometrial muscle, such as long-term steroid use\n15. Currently on anticoagulants\n16. Abnormal or obstructed cavity as confirmed by hysteroscopy or SIS, specifically:\n\n 1. Septate or bicornuate uterus or other congenital malformation of the uterine cavity\n 2. Pedunculated or submucosal myomas distorting the uterine cavity\n 3. Polyps likely to be the cause of the subject's menorrhagia\n 4. Intramural or subserosal myomas that distort the uterine cavity\n17. Presence of an intrauterine device (IUD)\n18. Subject currently on hormonal birth control therapy or unwilling to use a non-hormonal birth control post-ablation.\n19. Any general health condition which, in the opinion of the Investigator, could represent an increased risk for the subject\n20. Any subject who is participating in any other research of an investigational drug or device that has not yet completed the primary endpoint evaluation."}, 'identificationModule': {'nctId': 'NCT02035332', 'briefTitle': 'A Two-Phase Clinical Study of the Minerva AURORA Ablation System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Minerva Surgical, Inc.'}, 'officialTitle': 'A Two-Phase Clinical Study of the Minerva AURORA Ablation System', 'orgStudyIdInfo': {'id': 'CIP0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aurora Treatment Arm', 'description': 'Endometrial Ablation', 'interventionNames': ['Device: Aurora Endometrial Ablation System']}], 'interventions': [{'name': 'Aurora Endometrial Ablation System', 'type': 'DEVICE', 'description': 'Ablation of the endometrial lining of the uterus using the Aurora System', 'armGroupLabels': ['Aurora Treatment Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1115', 'city': 'Budapest', 'state': 'Budapest', 'country': 'Hungary', 'facility': 'Szt Imre Hospital', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '6725', 'city': 'Szeged', 'state': 'Csongrád megye', 'country': 'Hungary', 'facility': 'University of Szeged', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}, {'zip': '4043', 'city': 'Debrecen', 'state': 'Hajdú-Bihar', 'country': 'Hungary', 'facility': 'Kenézy Hospital', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minerva Surgical, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}