Computer-Assisted Versus Manual Hair Harvest Comparative Study

Not Applicable

Completed

Conditions: Androgenetic Alopecia

Interventions: Device: ARTAS™ System
Procedure: Manual Hair Harvest

Registration Number: NCT00926211

Lead Sponsor: Restoration Robotics, Inc.

Brief Summary: 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.

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 37

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Computer-Assisted	ARTAS™ System	Hair harvest using the computer-assisted system
Manual Harvest	Manual Hair Harvest	Hair harvesting via manual technique

Primary Outcome Measures

Name	Time	Method
Increase in Hair Follicles Present	Change from Baseline at 9 Months	The increase in the number of hair follicles present at follow-up in each region compared to the number present at baseline.

Secondary Outcome Measures

Name	Time	Method
Proportion of Harvested Follicles Transected	Time of harvest (Baseline)	The proportion of harvested hair follicles that were transected by each harvest method.

Trial Locations

Locations (2): Berman Skin Institute
🇺🇸
Palo Alto, California, United States
A Practice of Hair Restoration
🇺🇸
Walnut Creek, California, United States