Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2026-01-03 @ 11:46 PM
Study NCT ID:
NCT03427957
Status:
COMPLETED
Last Update Posted:
2020-04-20
First Post:
2018-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a New Hysteroscopic Grasper for Endometrial Biopsy in Post-menopausal Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Patients will be blinded to the type of grasper used to perform hysteroscopic endometrial biopsy.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-16', 'studyFirstSubmitDate': '2018-01-19', 'studyFirstSubmitQcDate': '2018-02-02', 'lastUpdatePostDateStruct': {'date': '2020-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of the hysteroscopy', 'timeFrame': 'During the hysteroscopy', 'description': 'Duration of the hysteroscopic procedure, expressed in minutes and seconds.'}, {'measure': 'Pain perceived by the patient', 'timeFrame': 'During the hysteroscopy', 'description': 'Subjective evaluation of the pain perceived by the patient during the procedure, expressed through a 0-10 Visual Analogue Scale (VAS) score, where 0 means "No pain" and 10 "The worst imaginable pain".'}], 'secondaryOutcomes': [{'measure': 'Number of attempts', 'timeFrame': 'During the hysteroscopy', 'description': 'Number of attempts necessary to perform the biopsy'}, {'measure': 'Size of the specimen', 'timeFrame': 'During the hysteroscopy', 'description': 'Size of the specimen obtained through biopsy, expressed in mm2'}, {'measure': 'Feasibility assessment by the operator', 'timeFrame': 'During the hysteroscopy', 'description': 'Subjective assessment by the operator of the feasibility of performing the biopsy, expressed through a 0-10 Visual Analogue Scale (VAS) score, where 0 means "No feasible at all" and 10 "The most feasible event I could imagine".'}, {'measure': 'Precision', 'timeFrame': 'During the hysteroscopy', 'description': 'Subjective assessment by the operator of the precision of the biopsy, expressed through a 0-10 Visual Analogue Scale (VAS) score, where 0 means "No precise at all" and 10 "The most precise event I could imagine".'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hysteroscopy', 'Endometrial biopsy', 'Menopause'], 'conditions': ['Post-Menopausal Bleeding', 'Post-Menopausal Endometrial Thickness']}, 'referencesModule': {'references': [{'pmid': '33686708', 'type': 'DERIVED', 'citation': 'Vitale SG, Lagana AS, Caruso S, Garzon S, Vecchio GM, La Rosa VL, Casarin J, Ghezzi F. Comparison of three biopsy forceps for hysteroscopic endometrial biopsy in postmenopausal patients (HYGREB-1): A multicenter, single-blind randomized clinical trial. Int J Gynaecol Obstet. 2021 Dec;155(3):425-432. doi: 10.1002/ijgo.13669. Epub 2021 Apr 4.'}]}, 'descriptionModule': {'briefSummary': 'Hysteroscopic endometrial biopsy is usually performed through the classic spoon grasper. Recently, a new hysteroscopic grasper with knurled terminal end and cutting jaws was designed, in order to improve feasibility of the procedure, reduce its duration and the discomfort for the patients.\n\nThis study aims to compare the outcomes of the three hysteroscopic graspers for endometrial biopsy in post-menopausal patients.', 'detailedDescription': 'Diagnostic hysteroscopy is currently the gold standard method to evaluate uterine cavity and tubal ostia, allowing also the visualization of vaginal walls and the cervical canal. Compared to the other available diagnostic techniques, hysteroscopy has the advantage of directly visualization the anatomical area to be investigated and allows to perform biopsy. The possibility of hysteroscopy-guided biopsy sampling is particularly important in order to get histological diagnosis. As recently suggested, the hysteroscopic biopsy of the endometrium has diagnostic accuracy of 90% for post-menopausal endometrial cancer.\n\nCurrently, most diagnostic hysteroscopies are performed in outpatient setting, without anesthesia, using modern hysteroscopes with a 1.67 mm working channel. In particular, endometrial biopsy is usually performed through the classic spoon grasper or alligator grasper. Recently, a new hysteroscopic grasper with knurled terminal end and cutting jaws was designed, in order to improve feasibility of the procedure, reduce its duration and the discomfort for the patients.\n\nThis study aims to compare the outcomes of the three hysteroscopic graspers for endometrial biopsy in post-menopausal patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physiologic menopause\n* Vaginal bleeding or endometrial thickness (\\>5 mm)\n\nExclusion Criteria:\n\n* Hormonal replacement therapies\n* Other known causes of vaginal/cervical bleeding\n* Suspected or known cancer(s)\n* Premature or iatrogenic menopause\n* Uterine cervix stenosis'}, 'identificationModule': {'nctId': 'NCT03427957', 'briefTitle': 'Evaluation of a New Hysteroscopic Grasper for Endometrial Biopsy in Post-menopausal Patients', 'organization': {'class': 'OTHER', 'fullName': "Università degli Studi dell'Insubria"}, 'officialTitle': 'Evaluation of a New Hysteroscopic Grasper for Endometrial Biopsy in Post-menopausal Patients With Vaginal Bleeding and/or Endometrial Thickness', 'orgStudyIdInfo': {'id': 'HYGREB-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'New hysteroscopic grasper', 'description': 'Patients allocated in this group will undergo hysteroscopic endometrial biopsy through the new grasper with knurled terminal end and cutting jaws.', 'interventionNames': ['Diagnostic Test: Endometrial biopsy with the new hysteroscopic grasper with knurled terminal end and cutting jaws']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Classic spoon grasper', 'description': 'Patients allocated in this group will undergo hysteroscopic endometrial biopsy through the classic spoon grasper.', 'interventionNames': ['Diagnostic Test: Endometrial biopsy with the hysteroscopic spoon grasper']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Classic alligator grasper', 'description': 'Patients allocated in this group will undergo hysteroscopic endometrial biopsy through the classic alligator grasper.', 'interventionNames': ['Diagnostic Test: Endometrial biopsy with the hysteroscopic alligator grasper']}], 'interventions': [{'name': 'Endometrial biopsy with the new hysteroscopic grasper with knurled terminal end and cutting jaws', 'type': 'DIAGNOSTIC_TEST', 'description': 'Hysteroscopic endometrial biopsy performed through the new grasper with knurled terminal end and cutting jaws.', 'armGroupLabels': ['New hysteroscopic grasper']}, {'name': 'Endometrial biopsy with the hysteroscopic spoon grasper', 'type': 'DIAGNOSTIC_TEST', 'description': 'Hysteroscopic endometrial biopsy performed through the spoon grasper.', 'armGroupLabels': ['Classic spoon grasper']}, {'name': 'Endometrial biopsy with the hysteroscopic alligator grasper', 'type': 'DIAGNOSTIC_TEST', 'description': 'Hysteroscopic endometrial biopsy performed through the alligator grasper.', 'armGroupLabels': ['Classic alligator grasper']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95100', 'city': 'Catania', 'country': 'Italy', 'facility': 'University of Catania', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'zip': '21100', 'city': 'Varese', 'country': 'Italy', 'facility': 'University of Insubria', 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}], 'overallOfficials': [{'name': 'Antonio Simone Laganà, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Università degli Studi dell'Insubria"}, {'name': 'Salvatore Giovanni Vitale, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Catania'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Università degli Studi dell'Insubria", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Antonio Simone Laganà', 'investigatorAffiliation': "Università degli Studi dell'Insubria"}}}}