Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-01-29 @ 12:14 PM
Study NCT ID:
NCT01979835
Status:
COMPLETED
Last Update Posted:
2020-04-28
First Post:
2013-10-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
GyneFix-Viz*: A Study of Serosal-Anchor (SA) Distance
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ellenwiebe@gmail.com', 'phone': '6047095611', 'title': 'Ellen Wiebe', 'organization': 'principal investigator'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Women Who Have a GyneFix Viz Inserted', 'description': 'GyneFix Viz: insertion of GyneFix Viz and measurment of the SA distance', 'otherNumAtRisk': 1012, 'deathsNumAtRisk': 1012, 'otherNumAffected': 180, 'seriousNumAtRisk': 1012, 'deathsNumAffected': 0, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'expulsion', 'notes': 'IUD expulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1012, 'numEvents': 36, 'numAffected': 36}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1012, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'too much bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1012, 'numEvents': 92, 'numAffected': 92}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'too much pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1012, 'numEvents': 27, 'numAffected': 27}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'vaginal discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1012, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1012, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0.1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Serosal-anchor Measurement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1012', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Women Who Have a GyneFix Viz Inserted', 'description': 'GyneFix Viz: insertion of GyneFix Viz and measurment of the SA distance'}], 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'spread': '2.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6-8 weeks', 'description': 'endovaginal ultrasound measurement of the distance from the anchor of the device and the serosal surface of the uterus', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1012', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Women Who Have a GyneFix Viz Inserted', 'description': 'GyneFix Viz: insertion of GyneFix Viz and measurment of the SA distance'}], 'classes': [{'title': 'Perforation', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Explusion', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}, {'title': 'Pregnancy', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Removed to conceive', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}]}]}, {'title': 'Removed because no longer needed', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Removed because >5 years', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}]}]}, {'title': 'Removed due to symptoms and other reasons', 'categories': [{'measurements': [{'value': '150', 'groupId': 'OG000'}]}]}, {'title': 'Removed, missing reason', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}]}]}, {'title': 'GyneFix in place', 'categories': [{'measurements': [{'value': '420', 'groupId': 'OG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 years', 'description': 'Number of participants with complications and removals at the end of the 5-year follow-up period', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Women Who Enrolled to Have a GyneFix Viz Inserted', 'description': 'GyneFix Viz: insertion of GyneFix Viz and measurment of the SA distance'}], 'periods': [{'title': 'Primary Outcome SA Measurment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1030'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1012'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'failed insertion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}]}]}, {'title': 'Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1012'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '980'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '32'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1030', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Women Enrolled to Have GF Inserted', 'description': 'All women requesting a GF and eligible for insertion who signed the informed consent document.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.7', 'spread': '6.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1030', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '1030', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1030}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-17', 'studyFirstSubmitDate': '2013-10-26', 'resultsFirstSubmitDate': '2020-03-03', 'studyFirstSubmitQcDate': '2013-11-07', 'lastUpdatePostDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-04-17', 'studyFirstPostDateStruct': {'date': '2013-11-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-03-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serosal-anchor Measurement', 'timeFrame': '6-8 weeks', 'description': 'endovaginal ultrasound measurement of the distance from the anchor of the device and the serosal surface of the uterus'}], 'secondaryOutcomes': [{'measure': 'Complications', 'timeFrame': '5 years', 'description': 'Number of participants with complications and removals at the end of the 5-year follow-up period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['intrauterine device, contraception'], 'conditions': ['Contraception']}, 'descriptionModule': {'briefSummary': 'The GyneFix-Viz is a frameless copper intrauterine device (IUD) used for contraception. The GyneFix IUD has been marketed in Europe and Asia for about 10 years. The new anchor in the GyneFix IUD was designed to be more visible on ultrasound and this could improve safety by reducing failed insertions and perforations. We now need to know how easy it is for doctors to see and measure the distance of the anchor to the outside of the uterus. The purpose of this open, prospective, observational study is to assess the feasibility of measuring the distance from the serosa of the uterus to the anchor following insertion of the GyneFix-Viz and at follow-up 6-8 weeks later. Secondary objectives are to assess the ease and pain of insertion, the acceptability of the device to Canadian women and any complications. We will also compare expulsion rates in post-abortion and other women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. healthy women requesting intrauterine contraception\n2. willing to have a GyneFix IUD for pregnancy prevention\n3. able to return for a follow-up ultrasound\n4. able to read and understand consent form\n\nExclusion Criteria:\n\n1. Any contraindications precluding insertion of an IUD (e.g., infection, cancer of the uterus, malformation etc.)\n2. Immediately after a pregnancy interruption \\> 10 weeks gestation'}, 'identificationModule': {'nctId': 'NCT01979835', 'acronym': 'GF', 'briefTitle': 'GyneFix-Viz*: A Study of Serosal-Anchor (SA) Distance', 'organization': {'class': 'OTHER', 'fullName': 'Wiebe, Ellen, M.D.'}, 'officialTitle': 'GYNEFIX-VIZ*: A STUDY OF SEROSAL-ANCHOR (SA) DISTANCE IN WOMEN IMMEDIATELY AND 6-8 WEEKS FOLLOWING INSERTION', 'orgStudyIdInfo': {'id': '130717'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GF', 'description': 'Women who have a GyneFix Viz inserted', 'interventionNames': ['Device: GyneFix Viz']}], 'interventions': [{'name': 'GyneFix Viz', 'type': 'DEVICE', 'description': 'insertion of GyneFix Viz and measurment of the SA distance', 'armGroupLabels': ['GF']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z1H9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "Willow Women's Clinic", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Ellen R WIEBE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of BC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wiebe, Ellen, M.D.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}