Computer-Assisted Hair Restoration Study Using ARTAS System

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

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Key information

Conditions

Androgenic Alopecia Alopecia Hair Diseases Hypotrichosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Berman Skin Institute, Los Altos, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hair restoration

Device

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

Primary outcomes

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

Time frame: 1 year post-treatment

Secondary outcomes

Percentage of follicles successfully harvested by Robot

Time frame: 1 year post-treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Director of Clinical Affairs, PhD

CONTACT

[email protected]

8889070115

Sponsors and collaborators

Lead sponsor

Venus Concept

Industry

Registry information

Important dates

Study start: 2016
Primary completion: 2026
Study completion: 2026
First posted: Jul 10, 2023
Registry last updated: Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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