Computer-Assisted Hair Restoration Study Using ARTAS System
ConditionAndrogenic Alopecia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age20-70
SponsorVenus Concept
About this trial
Prospective, multi-center, up to 4 investigational centers evaluating the performance of the ARTAS System in Hair Restoration Procedures.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Hair restoration
DeviceThe Study Treatment will involve follicular hair unit harvest, recipient site making, and implantation.
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: All subjectsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Hair Density from pre to 12 months post-treatment in robotic vs manual implantation
Time frame
1 year post-treatmentSecondary outcomes
1
Percentage of follicles successfully harvested by Robot
Time frame
1 year post-treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov