Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-02-20 @ 5:56 PM
Study NCT ID:
NCT01376934
Status:
UNKNOWN
Last Update Posted:
2011-06-20
First Post:
2011-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial of Hysteroscopy in Postmenopausal Women to Compare Techniques
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'lastUpdateSubmitDate': '2011-06-17', 'studyFirstSubmitDate': '2011-06-16', 'studyFirstSubmitQcDate': '2011-06-17', 'lastUpdatePostDateStruct': {'date': '2011-06-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the comfort in office hysteroscopy', 'timeFrame': 'one year', 'description': '140 women will undergo office hysteroscopy to evaluate pain, time of the procedure and image quality using two techniques one with gas and the other with saline solution.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hysteroscopy', 'saline solution', 'carbon dioxide', 'compare two techniques in office hysteroscopy co2 and saline solution'], 'conditions': ['Postmenopausal Women', 'Hysteroscopy']}, 'descriptionModule': {'briefSummary': 'Nowadays,hysteroscopy is a golden standard procedure to describe the morphology of uterine cavity and investigate of abnormal uterine bleeding . The success of the procedure is based on the distension of the cavity . It can cause pain and discomfort and sometimes the procedure fails. . There are two techniques to make the procedure , one with gas and the other with saline solution. Objective: to compare two techniques concerning pain , procedure duration and image quality', 'detailedDescription': 'The objective of this study is to compare two techniques in office hysteroscopy.In this clinical trial postmenopausal women will undergo a diagnostic hysteroscopy using carbon dioxide or saline solution to uterine cavity distension.\n\nThere will be two groups of 70 women each. The objective is to determine which technique provides better image,time of procedure and less discomfort.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women post-menopausal with abnormal uterine bleeding, ultrasound with thick endometrial distorted\n\nExclusion Criteria:\n\n* Women with uterine malformations\n* Women with mental retardation\n* Women underwent pelvic radiotherapy'}, 'identificationModule': {'nctId': 'NCT01376934', 'briefTitle': 'Clinical Trial of Hysteroscopy in Postmenopausal Women to Compare Techniques', 'organization': {'class': 'OTHER', 'fullName': 'University of Campinas, Brazil'}, 'officialTitle': 'Phase 1 Study of Two Techniques in Hysteroscopy That Compare Carbon Dioxide Versus Saline Solution', 'orgStudyIdInfo': {'id': '01/2011/PC'}}, 'armsInterventionsModule': {'interventions': [{'name': 'procedure hysteroscopy', 'type': 'PROCEDURE', 'description': 'office hysteroscopy with gas or saline solution'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13083881', 'city': 'Campinas', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Valter Fausto Santos, graduade medicine', 'role': 'CONTACT', 'email': 'valter.fausto@yahoo.com.br', 'phone': '5516 33717814', 'phoneExt': '203'}, {'name': 'Ilza Maria Monteiro, Doctor degree', 'role': 'CONTACT', 'email': 'ilza@unicamp.br', 'phone': '5516 97916241'}], 'facility': 'Departamento de Tocoginecologia FCM UNICAMP', 'geoPoint': {'lat': -22.90556, 'lon': -47.06083}}], 'overallOfficials': [{'name': 'Valter Fausto Santos', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Campinas, Brazil'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Campinas, Brazil', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Departamento de Toco-Ginecologia do CAISM', 'oldOrganization': 'UNICAMP'}}}}