Computer-Assisted Versus Manual Hair Harvest Comparative Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00926211
Recruitment Status : Completed
First Posted : June 23, 2009
Results First Posted : December 8, 2011
Last Update Posted : January 5, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Androgenetic Alopecia Device: ARTAS™ System Procedure: Manual Hair Harvest Not Applicable

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  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Computer-Assisted vs. Manual Hair Follicle Harvest: A Comparative Hair Count Study
Study Start Date : June 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Increase in Hair Follicles Present [ Time Frame: 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 :
  1. Proportion of Harvested Follicles Transected [ Time Frame: Time of harvest (Baseline) ]
    The proportion of harvested hair follicles that were transected by each harvest method.

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 59 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00926211

United States, California
Berman Skin Institute
Palo Alto, California, United States, 94304
A Practice of Hair Restoration
Walnut Creek, California, United States, 94596
Sponsors and Collaborators
Restoration Robotics, Inc.
Study Director: Miguel Canales, M.D. Restoration Robotics

Responsible Party: Restoration Robotics, Inc. Identifier: NCT00926211     History of Changes
Other Study ID Numbers: RR-09-0002
First Posted: June 23, 2009    Key Record Dates
Results First Posted: December 8, 2011
Last Update Posted: January 5, 2012
Last Verified: September 2011

Additional relevant MeSH terms:
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical