Actively Recruiting
Computer-Assisted Hair Restoration Study Using the ARTAS System for Androgenic Alopecia in Men
Led by Venus Concept · Updated on 2024-08-26
150
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the performance of the ARTAS System, a computer-assisted device, in hair restoration procedures for males with androgenic alopecia. This multi-center study aims to compare robotic implantation to manual implantation in terms of hair density improvement over one year. The study focuses on men aged 20 to 70 years diagnosed with Norwood-Hamilton grade III to VI androgenetic alopecia. The treatment involves follicular hair unit harvesting, creating recipient sites, and implanting hair follicles using the ARTAS robotic system. Participants will have their hair cut very short on the scalp areas designated for harvesting and implantation. All subjects receive the same study treatment during the procedure. Participants will be followed up for one year after treatment to assess changes in hair density and the percentage of follicles successfully harvested by the robot. Follow-up visits include post-operative evaluations per protocol. The study monitors the effectiveness of the robotic system compared to manual methods and tracks safety and treatment outcomes throughout the year-long period.
CONDITIONS
Brief Title
Computer-Assisted Hair Restoration Study Using ARTAS System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male with clinical diagnosis of androgenetic alopecia with Norwood-Hamilton grade III-VI
- Aged 20 to 70 years
- Willing to cut hair short (less than 1 mm) on the scalp in designated study areas
- Able to understand and provide written consent
- Willing to consent to post-operative follow-up per protocol
You will not qualify if you...
- Prior scalp reduction surgery within the past six months
- Bleeding diathesis
- Active use of anti-coagulation medication
- Any other condition that makes the subject inappropriate for the study, as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants undergo follicular hair unit harvest, recipient site making, and implantation using the ARTAS system for hair restoration.
1 procedure visit (in-person)
Duration - 12 months
Participants are monitored and assessed after the hair restoration procedure to evaluate treatment outcomes and safety.
Periodic follow-up visits over 12 months
Trial Site Locations
Total: 2 locations
1
Berman Skin Institute
Los Altos, California, United States, 94022
Completed
2
Le's Aesthetics
San Jose, California, United States, 95112
Actively Recruiting
Research Team
D
Director of Clinical Affairs, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here