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NCT05938569 Clinical Trial

Computer-Assisted Hair Restoration Study Using ARTAS System

Androgenic Alopecia Clinical Trial

Official title:
Computer-Assisted Hair Restoration Study Using ARTAS System

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05938569
Other study ID # CP-017
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 3, 2016
Est. completion date December 15, 2026

Study information
Verified date June 2024
Source Venus Concept
Contact Director of Clinical Affairs, PhD
Phone 8889070115
Email mgronski@venusconcept.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date December 15, 2026
Est. primary completion date December 15, 2026
Accepts healthy volunteers No
Gender Male
Age group 20 Years to 70 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Berman Skin Institute Los Altos California
United States Le's Aesthetics San Jose California

Sponsors (1)
Lead Sponsor Collaborator
Venus Concept

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Hair Density from pre to 12 months post-treatment in robotic vs manual implantation 1 year post-treatment
Secondary Percentage of follicles successfully harvested by Robot 1 year post-treatment
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