Computer-Assisted Versus Manual Hair Harvest Comparative Study

Restoration Robotics

Status

Completed

Conditions

Androgenetic Alopecia

Treatments

Device: ARTAS™ System

Procedure: Manual Hair Harvest

Study type

Interventional

Funder types

Industry

Identifiers

NCT00926211

RR-09-0002

Details and patient eligibility

About

The objective of this clinical study is to investigate and compare the safety and efficacy of the Restoration Robotics Computer-Assisted Harvesting System to the manual hair follicle harvesting method following a nine-month period of post-procedural evaluation.

Full description

A major technical step in hair transplantation is harvesting of the hair follicles. There are two accepted techniques for obtaining the hair grafts that are transplanted during the procedure. The first is donor strip harvest and stereomicroscopic dissection of the follicular unit grafts. The second is dissection and extraction of the follicular unit graft directly from the patient's scalp referred to as Follicular Unit Extraction or "FUE". Potential benefits of the FUE technique may be less scalp scarring in the Donor Area, less patient discomfort and faster wound healing. Although the FUE approach to harvest has highly desirable attributes, it is technically difficult to perform, labor intensive, tedious and requires an excessive amount of time to harvest follicular units. These procedural factors have prevented the FUE approach from gaining wider adoption.

Restoration Robotics, Inc. has developed the Restoration Robotics ARTAS™ Computer-Assisted Harvesting System to assist physicians in the harvest of hair follicles during hair transplantation procedures. The System mimics the manual FUE approach to harvesting follicular units and has the potential to solve the technical challenges inherent in the manual FUE technique. The ARTAS™ System is capable of identifying and harvesting hair follicles directly from the patient's scalp through a semi-automated process. The goal of the ARTAS™ System is to harvest the hair follicles while maintaining their critical anatomic structures intact.

Enrollment

37 patients

Sex

Male

Ages

30 to 59 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subject is male with clinical diagnosis of androgenic alopecia with Norwood-Hamilton grade of IV-VII
Subject is 30 to 59 years old
Subject has black or brown hair color
Subject has straight hair
Subject agrees to cut hair short (< 1 mm) on the scalp in the designated study areas for harvesting and implantation
Subject agrees to have two 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 preponderance of grey/white hair
Subject has blonde hair
Subject has red hair
Subject uses hair dye
Subject has prior history of hair restoration procedure(s) using the strip excision technique
Subject has prior history of scalp reduction surgery(s)
Subject has helical hair (curly hair)
Subject has wavy hair
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.