Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2025-12-25 @ 5:22 PM
Study NCT ID:
NCT04736095
Status:
COMPLETED
Last Update Posted:
2021-05-25
First Post:
2021-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
3 Dimensional Ultrasound in Comparison to Hysteroscopy in Myomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007889', 'term': 'Leiomyoma'}], 'ancestors': [{'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015907', 'term': 'Hysteroscopy'}], 'ancestors': [{'id': 'D003944', 'term': 'Diagnostic Techniques, Obstetrical and Gynecological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013513', 'term': 'Obstetric Surgical Procedures'}, {'id': 'D013509', 'term': 'Gynecologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-21', 'studyFirstSubmitDate': '2021-01-29', 'studyFirstSubmitQcDate': '2021-01-29', 'lastUpdatePostDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The accuracy of 3D ultrasound in doiagnosis of submucous myomas in comparison to hysteroscopy', 'timeFrame': 'one week', 'description': 'How many women will be diagnosed by 3D US to have submucous myoma'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fibroid']}, 'descriptionModule': {'briefSummary': '• three-dimensional saline infusion sonohysterography (3D SIS) was performed in all cases. A sterile Cuscoe speculum was passed, the cervix visualized and cleaned with sterile chlorhexidine solution. A 3.3 mm soft plastic paediatric naso-gastric suction catheter was then passed through the cervix into the uterine cavity without grasping the cervix.', 'detailedDescription': 'The speculum was removed and a 5 MHz transvaginal 3D ultrasound probe inserted into the vagina (Voluson 730; KretzTechnik, Austria).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women between 20 and 60 years with abnormal uterine bleeding', 'genderDescription': 'women with submucous myomas', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Women between 20 and 60 years with abnormal uterine bleeding in form of heavy menstrual bleeding, irregular and heavy menstrual bleeding) diagnosed on non-enhanced two-dimensional ultrasonography with submucous fibroids.\n\n * Absence of STD, PID, active vaginal bleeding.\n\nExclusion Criteria:\n\n* Presence of general cause of abnormal uterine bleeding\n\n * History of drug use that can cause vaginal bleeding (anticoagulants, OCPs, HRT)\n * History of recent hormonal treatment\n * High risk of undergoing hysteroscopy\n * Vaginal, Vulval causes of bleeding'}, 'identificationModule': {'nctId': 'NCT04736095', 'briefTitle': '3 Dimensional Ultrasound in Comparison to Hysteroscopy in Myomas', 'organization': {'class': 'OTHER', 'fullName': 'Aljazeera Hospital'}, 'officialTitle': '3 Dimensional Ultrasound in Comparison to Hysteroscopy in Diagnosis of Myomas', 'orgStudyIdInfo': {'id': '3D'}}, 'armsInterventionsModule': {'armGroups': [{'label': '3D ultrasound for diagnosis of submucous myomas', 'interventionNames': ['Diagnostic Test: 3D Ultrasound']}, {'label': 'Hysteroscopy for diagnosis of submucous myoma', 'interventionNames': ['Diagnostic Test: Hysteroscopy']}], 'interventions': [{'name': '3D Ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'Doing 3D ultrasound for diagnosis of submucous myoma', 'armGroupLabels': ['3D ultrasound for diagnosis of submucous myomas']}, {'name': 'Hysteroscopy', 'type': 'DIAGNOSTIC_TEST', 'description': 'Doing hysteroscopy for diagnosis of submucous myoma', 'armGroupLabels': ['Hysteroscopy for diagnosis of submucous myoma']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'country': 'Egypt', 'facility': 'Algazeerah', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}, {'city': 'Giza', 'country': 'Egypt', 'facility': 'Aljazeera( Al Gazeera) hospital', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'overallOfficials': [{'name': 'Mahmoud Alalfy, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Algezeera hospitaland National Research Centre ,Egypt'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aljazeera Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cairo University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}