Ignite Creation Date:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2026-02-27 @ 7:29 PM
Study NCT ID:
NCT02020733
Status:
COMPLETED
Last Update Posted:
2013-12-25
First Post:
2013-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Pain During Hysterosalpingography With The Use Of Balloon Catheter Versus Metal Cannula
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']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 194}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-24', 'studyFirstSubmitDate': '2013-12-19', 'studyFirstSubmitQcDate': '2013-12-24', 'lastUpdatePostDateStruct': {'date': '2013-12-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the degree of pain experienced during the procedure', 'timeFrame': '1 hour after the procedure', 'description': 'The primary outcome was the degree of pain experienced during the procedure, pain was evaluated with the Wong Baker Faces Pain Rating Scale (WBS), which ranked the pain from 0 to 5.'}]}, 'conditionsModule': {'keywords': ['Hysterosalpingography', 'balloon catheter', 'metal cannula', 'pain assessment'], 'conditions': ['Pain During Hysterosalpingography']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the metal cannula routinely used in our clinical practice with intrauterine hysterosalpingography catheter as a probable alternative device in a prospective, single-blinded, randomized study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '47 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged between 18-47 years,\n* applying for basic infertility evaluation to the Reproductive Endocrinology unit\n\nExclusion Criteria:\n\n* The patients with a known hypersensitivity to iodine or radio-opaque contrast dye,\n* vaginal bleeding,\n* genital malignancy and\n* any sign of pelvic inflammatory disease (PID) were excluded'}, 'identificationModule': {'nctId': 'NCT02020733', 'briefTitle': 'Evaluation of Pain During Hysterosalpingography With The Use Of Balloon Catheter Versus Metal Cannula', 'organization': {'class': 'OTHER', 'fullName': "Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital"}, 'orgStudyIdInfo': {'id': '20.12.13/160'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'balloon catheter', 'interventionNames': ['Device: Balloon catheter']}, {'type': 'OTHER', 'label': 'metal cannula', 'interventionNames': ['Device: metal cannula']}], 'interventions': [{'name': 'Balloon catheter', 'type': 'DEVICE', 'armGroupLabels': ['balloon catheter']}, {'name': 'metal cannula', 'type': 'DEVICE', 'armGroupLabels': ['metal cannula']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06010', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': "Etlik Zubeyde Hanim Women's Health Teaching and Research Hospital", 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sadiman Kiykac Altinbas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'M. D.', 'investigatorFullName': 'Sadiman Kiykac Altinbas', 'investigatorAffiliation': "Etlik Zubeyde Hanim Womens' Health and Teaching Hospital"}}}}