Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 11:07 PM
Study NCT ID:
NCT01539460
Status:
UNKNOWN
Last Update Posted:
2017-05-12
First Post:
2012-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Minimally Invasive Surgery for Axillary Osmidrosis: Combined Liposuction With Subcutaneous Pruning
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013543', 'term': 'Sweat Gland Diseases'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-11', 'studyFirstSubmitDate': '2012-02-21', 'studyFirstSubmitQcDate': '2012-02-24', 'lastUpdatePostDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-02-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the effectiveness of the refined minimally invasive procedure for radical treatment of axillary osmidrosis using patient self-report assessments', 'timeFrame': 'up to 24 months', 'description': 'the satisfaction of patients'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Axillary osmidrosis', 'liposuction', 'minimally invasive surgery'], 'conditions': ['Sweat Gland Diseases']}, 'descriptionModule': {'briefSummary': 'Patients with axillary osmidrosis are treated with minimally invasive procedure combined tumescent liposuction with Subcutaneous Pruning. Effectiveness of this modified method in reducing odor is to be determined.', 'detailedDescription': 'Patients with excessive malodor are recruited. They are surgically treated with minimally invasive procedure combined tumescent liposuction with Subcutaneous Pruning and followed up for 6-24 months to evaluate effectiveness sand side effect.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* unpleasant odor from the axillae\n* Willing and able to appear for all scheduled, post-operative visits\n\nExclusion Criteria:\n\n* under the age of 18\n* have undergone a prior surgical intervention\n* inappropriate candidates for surgery due to medical or mental health reasons\n* elect not to participate in the study'}, 'identificationModule': {'nctId': 'NCT01539460', 'briefTitle': 'A Minimally Invasive Surgery for Axillary Osmidrosis: Combined Liposuction With Subcutaneous Pruning', 'organization': {'class': 'OTHER', 'fullName': 'Tang-Du Hospital'}, 'officialTitle': 'A Refined Minimally Invasive Procedure for Radical Treatment of Axillary Osmidrosis: Combined Tumescent Liposuction With Subcutaneous Pruning Through a Small Incision', 'orgStudyIdInfo': {'id': 'TDH0369'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'minimally invasive surgery', 'description': 'There is only one arm to this study. All patients will receive treatment with the minimally invasive surgery for their axillary bromidrosis', 'interventionNames': ['Procedure: minimally invasive surgery']}], 'interventions': [{'name': 'minimally invasive surgery', 'type': 'PROCEDURE', 'description': 'Subcutaneous fat and apocrine sweat glands were removed by suction under tumescent anesthesia,and the remaining tissue and glands, tightly attached to the epidermis-dermis interface, were completely removed with scissors through the initial small incision.', 'armGroupLabels': ['minimally invasive surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710038', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'Yuejun Li', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'overallOfficials': [{'name': 'XUEYONG LI, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Plastics and Burns, Tangdu Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tang-Du Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'YUEJUN LI', 'investigatorAffiliation': 'Tang-Du Hospital'}}}}