Computer-Assisted Hair Restoration Study Using ARTAS System
Not Applicable
Recruiting
- Conditions
- Androgenic Alopecia
- Registration Number
- NCT05938569
- Lead Sponsor
- Venus Concept
- Brief Summary
Prospective, multi-center, up to 4 investigational centers evaluating the performance of the ARTAS System in Hair Restoration Procedures.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 150
Inclusion Criteria
- Subject is male with clinical diagnosis of androgenetic alopecia with Norwood-Hamilton grade of III-VI
- Subject is 20 to 70 years old
- Subject agrees to cut hair short (< 1 mm) on the scalp in the designated study areas for harvesting and implantation
- Subject is able to understand and provide written consent
- Subject consents to post-operative follow-up per protocol
Exclusion Criteria
- Subject has prior history of scalp reduction surgery(s) in the past six months
- Subject has bleeding diathesis
- Subject has active use of anti-coagulation medication
- Subject has any other condition that, in the opinion of the investigator, makes the subject inappropriate to take part in this study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Change in Hair Density from pre to 12 months post-treatment in robotic vs manual implantation 1 year post-treatment
- Secondary Outcome Measures
Name Time Method Percentage of follicles successfully harvested by Robot 1 year post-treatment
Trial Locations
- Locations (2)
Berman Skin Institute
🇺🇸Los Altos, California, United States
Le's Aesthetics
🇺🇸San Jose, California, United States
Berman Skin Institute🇺🇸Los Altos, California, United States