Computer-Assisted Hair Restoration Study Using ARTAS System

Venus Concept

Status: Enrolling

Conditions: Androgenic Alopecia

Treatments: Device: Hair restoration

Study type: Interventional

Funder types: Industry

Identifiers

NCT05938569

CP-017

Details and patient eligibility

About

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

Enrollment: 150 estimated patients

Sex: Male

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

All subjects

Experimental group

Description:

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

Treatment:

Device: Hair restoration