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Clinical Trials in the USA / NCT05938569
Recruiting Not applicable

Computer-Assisted Hair Restoration Study Using ARTAS System

NCT05938569 · tracked via the Priya Life Science USA tracker
Sponsor
Venus Concept
Phase
Not applicable
Started
2016-11-03
Last updated
2024-08-26

Condition(s) studied

Androgenic Alopecia

Investigational drug(s) / intervention(s)

Hair restoration

Hair restoration: The Study Treatment will involve follicular hair unit harvest, recipient site making, and implantation.

Study summary

Prospective, multi-center, up to 4 investigational centers evaluating the performance of the ARTAS System in Hair Restoration Procedures.

Eligibility

Sex
MALE
Min age
20 Years
Max age
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

Primary outcome measure(s)

  • Change in Hair Density from pre to 12 months post-treatment in robotic vs manual implantation — 1 year post-treatment

Trial sites (2)

FacilityCityRegionStatus
Berman Skin Institute Los Altos California Completed
Le's Aesthetics San Jose California Recruiting

More Venus Concept trials in the USA

Electrical Muscle Stimulation with 1064 Nm Diode Laser and RF/PEMF for Non-invasive Body Contouring and Fat Reduction. Active, not recruiting

Other trials for the same condition

Autologous Hair Follicle Secretome for Androgenic Alopecia (Single Site) Recruiting
Study to Evaluate Xtressé Gummy Supplement in Men With Androgenic Alopecia Enrolling by invitation
A Clinical Study to Evaluate the Efficacy and Safety of Ultra in Promoting Hair Regrowth Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05938569 on ClinicalTrials.gov ↗ ← All trials in the USA