Computer-Assisted Hair Implantation Using ARTAS System VS Manual Implantation Technique Hair Restoration Study

Restoration Robotics

Status

Unknown

Conditions

Androgenic Alopecia

Treatments

Other: Manual Implantation

Device: ARTAS System

Study type

Interventional

Funder types

Industry

Identifiers

NCT02914587

CP-003

Details and patient eligibility

About

To investigate and compare the safety and effectiveness of the ARTAS™ System to manual hair follicle implantation method following a nine month period of post-procedure evaluation.

Full description

This comparative study is a multi-center, prospective, blinded, randomized controlled clinical study where subjects act as their own control.

The purpose of this study is to demonstrate that the ARTAS System is safe and effective for implanting follicular hair units.

Patients will be followed for a nine months period of time.

Enrollment

32 patients

Sex

Male

Ages

29 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject is male with clinical diagnosis of androgenetic alopecia with Norwood-Hamilton grade of IV-VI;
Subject is 29 to 70 years old;
Subject has black or brown hair color;
Subject has straight hair;
Subject agrees to cut hair short (about 1-1.4 mm) on the scalp in the designated study areas for harvesting and implantation;
Subject agrees to have 6 dot tattoos placed on scalp;
Subject is able to understand and provide written consent; and
Subject consents to post-operative follow-up per protocol.

Exclusion criteria

Subject has prior history of scalp reduction surgery(s);
Subject has prior history of hair restoration procedure(s) using the strip excision technique;
Subject has bleeding diathesis;
Subject has active use of anti-coagulation medication;
Subject has used finasteride in the previous 6 months, or plans to use finasteride during the study;
Subject has used minoxidil in the previous 2 weeks, or plans to use minoxidil during the study; or
Subject has any other condition that, in the opinion of the investigator, makes the subject inappropriate to take part in this study.