Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT07128459
Status:
COMPLETED
Last Update Posted:
2025-08-19
First Post:
2025-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lip Reduction Surgery for Port-wine Macrocheilia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018324', 'term': 'Hemangioma, Capillary'}], 'ancestors': [{'id': 'D006391', 'term': 'Hemangioma'}, {'id': 'D009383', 'term': 'Neoplasms, Vascular Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2025-08-13', 'studyFirstSubmitQcDate': '2025-08-13', 'lastUpdatePostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the Visual Analog Scale', 'timeFrame': 'From enrollment to the end of treatment in 6 months to one year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Port Wine Stains']}, 'descriptionModule': {'briefSummary': 'Patients with port-wine stains often develop macrocheilia, however, there is currently no effective treatment to significantly reduce the three-dimensional volume increase of the lips. This article presents a simplified "five-step" approach based on clinical experience, designed to assist inexperienced surgeons in performing this surgery effectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: 1. Patients with port-wine macrocheilia. 2. Patients that underwent lip reduction surgery. 3. Age at surgery: ≥3 years and ≤70 years.\n\nExclusion Criteria: 1. Patients without port-wine macrocheilia. 2. Missing/incomplete baseline patient information. 3. Patients without postoperative photographs.'}, 'identificationModule': {'nctId': 'NCT07128459', 'acronym': 'macrocheilia', 'briefTitle': 'Lip Reduction Surgery for Port-wine Macrocheilia', 'organization': {'class': 'OTHER', 'fullName': "Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University"}, 'officialTitle': 'Lip Reduction Surgery for Port-wine Macrocheilia: a Retrospective Single-center Clinical Study', 'orgStudyIdInfo': {'id': 'SH9H-2025-T313-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with port-wine macrocheilia who underwent lip reduction surgery using the five-step method', 'interventionNames': ['Procedure: The Five-Step lip reduction surgery']}], 'interventions': [{'name': 'The Five-Step lip reduction surgery', 'type': 'PROCEDURE', 'description': 'The Five-Step lip reduction surgery: (1) measurement and design; (2) incision and reduction of lip volume; (3) fixation and shape of the dry lip; (4) fixation and shape of the skin (the SMISS approach); (5) shaping of the wet lip mucosa (the SMISS approach).', 'armGroupLabels': ['Patients with port-wine macrocheilia who underwent lip reduction surgery using the five-step method']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'country': 'China', 'facility': "Shanghai Ninth People's Hospital, Shanghai Jiao Tong University, School of Medicine", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Chief Physician', 'investigatorFullName': 'Gang Ma', 'investigatorAffiliation': "Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University"}}}}