Ignite Creation Date:
2025-12-25 @ 1:09 AM
Ignite Modification Date:
2025-12-25 @ 11:20 PM
Study NCT ID:
NCT00735293
Status:
COMPLETED
Last Update Posted:
2008-09-19
First Post:
2008-08-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
VASER Treatment of Axillary Hyperhidrosis/Bromidrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006945', 'term': 'Hyperhidrosis'}, {'id': 'D000089083', 'term': 'Body Odor'}], 'ancestors': [{'id': 'D013543', 'term': 'Sweat Gland Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-09-17', 'studyFirstSubmitDate': '2008-08-12', 'studyFirstSubmitQcDate': '2008-08-13', 'lastUpdatePostDateStruct': {'date': '2008-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the effectiveness of the VASER for treatment of axillary hyperhidrosis using patient self-report assessments', 'timeFrame': '6 months'}, {'measure': 'To assess the effectiveness of the VASER for the treatment of axillary bromidrosis using patient self report assessment', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': "To assess patient's post-operative pain level following VASER using patient self report assessments.", 'timeFrame': '2 months'}, {'measure': 'To assess patients healing time following VASER treatment of axillary hyperhidrosis', 'timeFrame': '6 months'}, {'measure': 'To establish safe and effective procedural guidelines and surgical endpoints for the treatment of axillary hyperhidrosis using the VASER', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hyperhidrosis', 'bromidrosis', 'bromhidrosis', 'osmidrosis', 'hircismus', 'excessive', 'underarm', 'sweat', 'perspiration', 'Body Odor'], 'conditions': ['Axillary Hyperhidrosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://vaser.com', 'label': 'Sound VASER System'}]}, 'descriptionModule': {'briefSummary': "Patients with excessive underarm odor and sweating and/or odor are treated with the VASER system to determine the VASER's effectiveness in reducing underarm sweat and odor", 'detailedDescription': 'Patients with excessive underarm sweat and/or odor are recruited. The effect that excessive underarm sweat and/or odor has on their lifestyle is evaluated. They are surgically treated with the VASER system and followed up for 6 months to evaluate side effects, adverse events and effectiveness. Additional lifestyle evaluations are completed for comparison to pre-surgery answers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Willing and able to appear for all scheduled, post-operative visits\n* Have axillary hyperhidrosis/bromidrosis that does not respond to conventional, non-invasive treatment\n\nExclusion Criteria:\n\n* under the age of 18\n* have undergone a prior surgical intervention for treatment of axillary hyperhidrosis (e.g.) Skoog procedure, ETS)\n* have been treated with a systemic or topical agent for axillary hyperhidrosis in the past 30 days\n* are deemed inappropriate candidates for surgery due to medical or mental health reasons\n* are currently being treated with investigational agents or have participated in an investigational study within 60 days prior to surgery\n* elect not to participate in the study'}, 'identificationModule': {'nctId': 'NCT00735293', 'acronym': 'VASER AxHH', 'briefTitle': 'VASER Treatment of Axillary Hyperhidrosis/Bromidrosis', 'organization': {'class': 'OTHER', 'fullName': 'Commons Aesthetic Plastic Surgery'}, 'officialTitle': 'The Use of the VASER System in the Treatment of Axillary Hyperhidrosis and/or Axillary Bromidrosis', 'orgStudyIdInfo': {'id': 'VASER AxHH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Treatment', 'description': 'There is only one arm to this study. All patients will receive treatment with the VASER for their axillary hyperhidrosis/bromidrosis', 'interventionNames': ['Device: VASER']}], 'interventions': [{'name': 'VASER', 'type': 'DEVICE', 'otherNames': ['Sound VASER System'], 'description': 'A small incision will be made in the underarm. A VASER probe will be inserted under the skin to break apart fat and sweat glands under the skin. A small hollow tube will be used to draw out the broken-down skin and the incision will be closed with a stitch.', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94306', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Commons Aesthetic Plastic Surgery', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Commons Aesthetic Plastic Surgery', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sound Surgical Technologies, LLC.', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'George W. Commons, M.D.', 'oldOrganization': 'Commons Aesthetic Plastic Surgery'}}}}