Androgenic Alopecia
Conditions
Brief summary
Prospective, multi-center, up to 4 investigational centers evaluating the performance of the ARTAS System in Hair Restoration Procedures.
Interventions
DEVICEHair restoration
The Study Treatment will involve follicular hair unit harvest, recipient site making, and implantation.
Sponsors
Venus Concept
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Hair Density from pre to 12 months post-treatment in robotic vs manual implantation | 1 year post-treatment |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of follicles successfully harvested by Robot | 1 year post-treatment |
Countries
United States
Contacts
Primary ContactDirector of Clinical Affairs, PhD
Outcome results
None listed