Recruiting NCT05938569
Computer-Assisted Hair Restoration Study Using ARTAS System
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hair restoration.
- Who it may be relevant to
- Registry conditions: Androgenic Alopecia. Basic parameters: 20 years — 70 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
Prospective, multi-center, up to 4 investigational centers evaluating the performance of the ARTAS System in Hair Restoration Procedures.
Interventions
- Device Hair restoration
The Study Treatment will involve follicular hair unit harvest, recipient site making, and implantation.
Primary outcome measures
- Change in Hair Density from pre to 12 months post-treatment in robotic vs manual implantation [Time frame: 1 year post-treatment]
Secondary outcome measures (1)
- Percentage of follicles successfully harvested by Robot [Time frame: 1 year post-treatment]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Berman Skin Institute — Los Altos
- Le's Aesthetics — San Jose
Identifiers
NCT: NCT05938569 · CP-017