Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-31 @ 1:10 AM
Study NCT ID:
NCT05363735
Status:
WITHDRAWN
Last Update Posted:
2024-04-19
First Post:
2022-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Elastography Application in Cesarean Section Scar Defect
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': "Device can't meet the requirements", 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-17', 'studyFirstSubmitDate': '2022-03-19', 'studyFirstSubmitQcDate': '2022-05-05', 'lastUpdatePostDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'thickness of the remaining muscular layer', 'timeFrame': '4 weeks before vaginal repair of CSD', 'description': 'The thickness of the remaining muscular layer is measured by ultrasound'}, {'measure': 'thickness of the remaining muscular layer', 'timeFrame': '12 weeks after vaginal repair of CSD', 'description': 'The thickness of the remaining muscular layer is measured by ultrasound'}, {'measure': 'strain ratio (SR)', 'timeFrame': '4 weeks before vaginal repair of CSD', 'description': 'the ratio of mean strain in the lesion to the adjacent background tissue'}, {'measure': 'strain ratio (SR)', 'timeFrame': '12 weeks after vaginal repair of CSD', 'description': 'the ratio of mean strain in the lesion to the adjacent background tissue'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cesarean Section; Dehiscence']}, 'descriptionModule': {'briefSummary': 'Cesarean Section Scar Defect(CSD) is one of the complications after cesarean section. CSD will cause many long term complications, such as abnormal uterine bleeding, infertility, uterine scar pregnancy and uterine rupture. Transvaginal ultrasound was used to detect uterine scar defects commonly. Ultrasound elastography is a modern imaging technique that has developed rapidly in recent years. Thus, this study intend to investigate the application of Ultrasound Elastography in Cesarean Section Scar Defect.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'women who were diagnosed with CSD', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clearly diagnosed with CSD\n* No serious medical problems (important viscera function in the normal range). uterine fibroids no more than 5cm\n* Sign the informed consent.\n\nExclusion Criteria:\n\n* Indefinite diagnosis.\n* Malignant tumors.\n* With severe medical problems (severe liver disease, kidney disease, respiratory diseases, heart disease or uncontrolled diabetes, epilepsy, etc., dysfunction of important organs).\n* Pregnant.\n* Mental diseases.\n* Unwilling to comply with the research plan.'}, 'identificationModule': {'nctId': 'NCT05363735', 'briefTitle': 'Ultrasound Elastography Application in Cesarean Section Scar Defect', 'organization': {'class': 'OTHER', 'fullName': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Ultrasound Elastography Application in the Assessment of Cesarean Section Scar Defect.', 'orgStudyIdInfo': {'id': 'XH-21-015'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ultrasound Elastography', 'description': 'Patients will be examined by ultrasound elastography.', 'interventionNames': ['Other: Ultrasound Elastography']}], 'interventions': [{'name': 'Ultrasound Elastography', 'type': 'OTHER', 'description': 'Patients will be examined by ultrasound elastography.', 'armGroupLabels': ['Ultrasound Elastography']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200092', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Wang Xipeng, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}