Computer-Assisted Versus Manual Hair Harvest Comparative Study

Safety and Efficacy of Computer-Assisted vs. Manual Hair Follicle Harvest: A Comparative Hair Count Study

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.

Study Overview

• Status: Completed
• Conditions: Androgenetic Alopecia
• Intervention / Treatment: Device: ARTAS™ System; Procedure: Manual Hair Harvest

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.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Berman Skin Institute
    • Walnut Creek, California, United States, 94596
      • A Practice of Hair Restoration

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 59 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Computer-Assisted; Hair harvest using the computer-assisted system	Device: ARTAS™ System; Hair harvest using a computer-assisted system
ACTIVE_COMPARATOR: Manual Harvest; Hair harvesting via manual technique	Procedure: Manual Hair Harvest; Hair harvesting via the manual technique

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Harvested Follicles Transected	The proportion of harvested hair follicles that were transected by each harvest method.	Time of harvest (Baseline)

Collaborators and Investigators

• Sponsor: Restoration Robotics, Inc.
• Investigators: Study Director: Miguel Canales, M.D., Restoration Robotics

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (ACTUAL): September 1, 2010
• Study Completion (ACTUAL): September 1, 2010

Study Registration Dates

• First Submitted: June 19, 2009
• First Submitted That Met QC Criteria: June 22, 2009
• First Posted (ESTIMATE): June 23, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): January 5, 2012
• Last Update Submitted That Met QC Criteria: January 3, 2012
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia
• Other Study ID Numbers: RR-09-0002