Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 11:54 PM
Study NCT ID:
NCT04373694
Status:
UNKNOWN
Last Update Posted:
2023-01-12
First Post:
2020-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaginoscopy Compared to Traditional Hysteroscopy for Hysteroscopy Morcellation in Outpatient Clinic. A Randomized Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047708', 'term': 'Myofibroma'}], 'ancestors': [{'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 78}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-11', 'studyFirstSubmitDate': '2020-04-23', 'studyFirstSubmitQcDate': '2020-05-01', 'lastUpdatePostDateStruct': {'date': '2023-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in pain perception between vaginoscopy group and traditional hysteroscopy group', 'timeFrame': 'immediately after intervention', 'description': '10 point visual analog pain scale: 0 for no pain to 10 for unbearable pain'}], 'secondaryOutcomes': [{'measure': 'Difference in length of time of procedure between vaginoscopy group and traditional hysteroscopy group', 'timeFrame': 'immediately after intervention', 'description': 'length of time in minutes between start and end of procedure including morcellation'}, {'measure': 'Difference in proportion of vasovagal syncope between vaginoscopy group and traditional hysteroscopy group', 'timeFrame': 'immediately after surgery', 'description': 'Presence of jerky abnormal movements or a slow weak pulse rate associated to at least one symptoms: nausea, pale skin, blurred vision, warm feeling or cold sweat.'}, {'measure': 'Difference in proportion of uterine perforation between vaginoscopy group and traditional hysteroscopy group', 'timeFrame': 'immediatly after surgery', 'description': 'presence of one or more signs during intervention: extension of the instrument goes beyong the limitation of the uterus, loss of resistance, sudden loss of vision, direct visualisation of the perforation'}, {'measure': 'Difference in length of time to continue fertility treatment between vaginoscopy group and traditional hysteroscopy group', 'timeFrame': 'up to 1 year', 'description': 'length of time in months to continue fertility treatment after procedure'}, {'measure': 'Difference in length of time to pregnancy between vaginoscopy group and traditional hysteroscopy group', 'timeFrame': 'up to 1 year', 'description': 'length of time in months to be pregnant after procedure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vaginoscopy', 'hysteroscopy morcellation', 'infertile population'], 'conditions': ['Leiomyoma of Uterus']}, 'descriptionModule': {'briefSummary': "This study is a randomized controlled trial take place in a fertility outpatient clinic in an academic hospital. Women between 18 and 52 years old requiring polypectomy or myomectomy by hysteroscopy morcellation for abnormal uterine bleeding or for fertility issue are included. The aim is to evaluate pain perception between vaginal and traditional hysteroscopy for hysteroscopic morcellation. The investigator's hypothesis is that pain perception is lower using vaginoscopy compared to traditional hysteroscopy.", 'detailedDescription': '78 participants will be randomised in two groups:\n\n1. traditional hysteroscopy: under intravenous sedation, hysteroscopic morcellation is perform after speculum insertion, vaginal cleansing, and paracervical anesthesia with xylocain 1%.\n2. Vaginal hysteroscopy: under intravenous sedation, hysteroscopic morcellation is perform after vaginal cleansing using vaginal distension with saline solution\n\nIn addition to pain perception, other outcomes includes: complication rates, time to continue fertility treatment, time to pregnancy'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '52 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* polyp or fibroid previously diagnosed by hysteroscopy\n* polyp less than 2 cm\n* submucosal fibroid (type 0 or 1 according to the 2011 FIGO uterine fibroid classification) less than 2 cm\n* if more than 1 fibroid: total fibroid have to be less or equal 4 cm\n\nExclusion Criteria:\n\n* cervical stenosis\n* polyp or fibroid more than 2 cm\n* pregnancy\n* blood dyscrasia'}, 'identificationModule': {'nctId': 'NCT04373694', 'briefTitle': 'Vaginoscopy Compared to Traditional Hysteroscopy for Hysteroscopy Morcellation in Outpatient Clinic. A Randomized Trial', 'organization': {'class': 'OTHER', 'fullName': "Centre hospitalier de l'Université de Montréal (CHUM)"}, 'officialTitle': 'Pain Perception During Vaginoscopy Compared to Traditional Hysteroscopy for Hysteroscopy Morcellation in Outpatient Clinic: A Randomized Trial', 'orgStudyIdInfo': {'id': '19.380'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard hysteroscopy', 'description': 'morcellation hysteroscopy with intravenous sedation and paracervical bloc', 'interventionNames': ['Procedure: standard hysteroscopy']}, {'type': 'EXPERIMENTAL', 'label': 'Vaginoscopy', 'description': 'morcellation hysteroscopy with only intravenous sedation', 'interventionNames': ['Procedure: vaginoscopy']}], 'interventions': [{'name': 'vaginoscopy', 'type': 'PROCEDURE', 'description': 'vaginal distension with hysteroscope for hysteroscopy morcellation (without speculum or tenaculum forceps)', 'armGroupLabels': ['Vaginoscopy']}, {'name': 'standard hysteroscopy', 'type': 'PROCEDURE', 'description': 'speculum, paracervical block before hysteroscopy morcellation', 'armGroupLabels': ['Standard hysteroscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H2X 1P1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHUM - Clinique Médecine et biologie de la reproduction', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Carole KAMGA-NGANDE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Centre hospitalier de l'Université de Montréal (CHUM)"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre hospitalier de l'Université de Montréal (CHUM)", 'class': 'OTHER'}, 'collaborators': [{'name': 'Hologic, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}