Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-28 @ 1:06 AM
Study NCT ID:
NCT06188858
Status:
COMPLETED
Last Update Posted:
2024-01-03
First Post:
2023-12-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimal Incision Site Design for Lymphaticovenular Anastomosis in Extremity Lymphedema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008209', 'term': 'Lymphedema'}], 'ancestors': [{'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 267}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-18', 'studyFirstSubmitDate': '2023-12-10', 'studyFirstSubmitQcDate': '2023-12-18', 'lastUpdatePostDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with lymphedema stage', 'timeFrame': 'through study completion, an average of 4 year', 'description': 'stage 0-3'}, {'measure': 'Number of Optimal Incision Site Design', 'timeFrame': 'through study completion, an average of 4 year', 'description': 'Optimal Incision Site Design for Lymphaticovenular Anastomosis'}, {'measure': 'Rate of lymphatic vessel Functional Parameters', 'timeFrame': 'through study completion, an average of 4 year', 'description': 'intraoperative functional lymphatic vessel assessment'}, {'measure': 'Circumferential Reduction rate', 'timeFrame': 'through study completion, an average of 4 year', 'description': 'postoperative limb reduction and patient satisfaction'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lymphedema']}, 'descriptionModule': {'briefSummary': "Our aim was to identify optimal incision sites for LVA in extremity lymphedema that would result in the most effective drainage effect for reducing limb edema and enhancing patients' quality of life.", 'detailedDescription': 'designing the optimal incision sites and identifying functional lymphatic vessels imaging is crucial for success, primarily due to its efficacy in draining edematous lymphatic fluid and reducing swelling in patients with lymphedema. In this study, we conducted patients with LVA lymphedema to investigate the correlation between LVA incision design, intraoperative functional lymphatic vessel assessment, postoperative limb reduction, and patient satisfaction.\n\nquestion 1：Optimal Incision Site Design for Lymphaticovenular Anastomosis in Extremity lymphedema'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Lymphedema patients', 'eligibilityCriteria': 'Inclusion Criteria: Aged 18-80 years; Lymphedema and swelling of the limbs for more than 3 months\n\n\\-\n\nExclusion Criteria:\n\n* lipedema；myoedema'}, 'identificationModule': {'nctId': 'NCT06188858', 'briefTitle': 'Optimal Incision Site Design for Lymphaticovenular Anastomosis in Extremity Lymphedema', 'organization': {'class': 'OTHER', 'fullName': 'Taizhou Hospital'}, 'officialTitle': 'Optimal Incision Site Design for Lymphaticovenular Anastomosis in Extremity', 'orgStudyIdInfo': {'id': 'Taizhou Hospital OISD'}}, 'contactsLocationsModule': {'locations': [{'zip': '318000', 'city': 'Zhejiang', 'country': 'China', 'facility': 'Chong Liu', 'geoPoint': {'lat': 25.3238, 'lon': 105.583}}], 'overallOfficials': [{'name': 'yomao zheng', 'role': 'STUDY_DIRECTOR', 'affiliation': 'employee'}, {'name': 'chong liu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'employee'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taizhou Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Physician', 'investigatorFullName': 'Haihua Yang', 'investigatorAffiliation': 'Taizhou Hospital'}}}}