Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2026-01-05 @ 5:50 PM
Study NCT ID:
NCT05938569
Status:
RECRUITING
Last Update Posted:
2024-08-26
First Post:
2023-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Computer-Assisted Hair Restoration Study Using ARTAS System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000505', 'term': 'Alopecia'}], 'ancestors': [{'id': 'D007039', 'term': 'Hypotrichosis'}, {'id': 'D006201', 'term': 'Hair Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-11-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-22', 'studyFirstSubmitDate': '2023-06-27', 'studyFirstSubmitQcDate': '2023-07-05', 'lastUpdatePostDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Hair Density from pre to 12 months post-treatment in robotic vs manual implantation', 'timeFrame': '1 year post-treatment'}], 'secondaryOutcomes': [{'measure': 'Percentage of follicles successfully harvested by Robot', 'timeFrame': '1 year post-treatment'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Androgenic Alopecia']}, 'descriptionModule': {'briefSummary': 'Prospective, multi-center, up to 4 investigational centers evaluating the performance of the ARTAS System in Hair Restoration Procedures.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is male with clinical diagnosis of androgenetic alopecia with Norwood-Hamilton grade of III-VI\n* Subject is 20 to 70 years old\n* Subject agrees to cut hair short (\\< 1 mm) on the scalp in the designated study areas for harvesting and implantation\n* Subject is able to understand and provide written consent\n* Subject consents to post-operative follow-up per protocol\n\nExclusion Criteria:\n\n* Subject has prior history of scalp reduction surgery(s) in the past six months\n* Subject has bleeding diathesis\n* Subject has active use of anti-coagulation medication\n* Subject has any other condition that, in the opinion of the investigator, makes the subject inappropriate to take part in this study'}, 'identificationModule': {'nctId': 'NCT05938569', 'briefTitle': 'Computer-Assisted Hair Restoration Study Using ARTAS System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Venus Concept'}, 'officialTitle': 'Computer-Assisted Hair Restoration Study Using ARTAS System', 'orgStudyIdInfo': {'id': 'CP-017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'All subjects', 'description': 'The Study Treatment will involve follicular hair unit harvest, recipient site making, and implantation.', 'interventionNames': ['Device: Hair restoration']}], 'interventions': [{'name': 'Hair restoration', 'type': 'DEVICE', 'description': 'The Study Treatment will involve follicular hair unit harvest, recipient site making, and implantation.', 'armGroupLabels': ['All subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94022', 'city': 'Los Altos', 'state': 'California', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Berman Skin Institute', 'geoPoint': {'lat': 37.38522, 'lon': -122.11413}}, {'zip': '95112', 'city': 'San Jose', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Vincent Le, D.O.', 'role': 'CONTACT', 'email': 'vle02@yahoo.com', 'phone': '408-835-9977'}, {'name': 'Lin Phong', 'role': 'CONTACT', 'email': 'infohaircenters@gmail.com', 'phone': '408-835-9977'}, {'name': 'Vincent Le', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Le's Aesthetics", 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}], 'centralContacts': [{'name': 'Director of Clinical Affairs, PhD', 'role': 'CONTACT', 'email': 'mgronski@venusconcept.com', 'phone': '8889070115'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Venus Concept', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}