Computer-assisted hair restoration using the ARTAS system
Computer-Assisted Hair Restoration Study Using ARTAS System
NA · Venus Concept · NCT05938569
This study is testing a new robotic system for hair restoration to see if it helps men with hair loss from androgenic alopecia.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 20 Years to 70 Years |
| Sex | Male |
| Sponsor | Venus Concept (industry) |
| Locations | 2 sites (Los Altos, California and 1 other locations) |
| Trial ID | NCT05938569 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the ARTAS System for hair restoration in men suffering from androgenic alopecia. It involves a prospective, multi-center approach across up to four investigational centers. Participants will undergo hair restoration procedures with the ARTAS technology, which utilizes advanced robotics for harvesting and implantation. The study aims to assess the performance and outcomes of this innovative method in treating hair loss.
Who should consider this trial
Good fit: Ideal candidates are males aged 20 to 70 with a clinical diagnosis of androgenetic alopecia at Norwood-Hamilton grades III to VI.
Not a fit: Patients with a history of recent scalp surgeries, bleeding disorders, or those on anticoagulation medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this could provide a more effective and precise method for hair restoration in men with androgenic alopecia.
How similar studies have performed: While the ARTAS system represents a novel approach, similar robotic-assisted hair restoration techniques have shown promising results in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Los Altos, California and 1 other locations
- Berman Skin Institute — Los Altos, California, United States (COMPLETED)
- Le's Aesthetics — San Jose, California, United States (RECRUITING)
Study contacts
- Study coordinator: Director of Clinical Affairs, PhD
- Email: mgronski@venusconcept.com
- Phone: 8889070115
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Androgenic Alopecia