Computer-Assisted Versus Manual Hair Harvest Comparative Study

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Brief Title

Computer-Assisted Versus Manual Hair Harvest Comparative Study

Official Title

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

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.
    


Study Type

Interventional


Primary Outcome

Increase in Hair Follicles Present

Secondary Outcome

 Proportion of Harvested Follicles Transected

Condition

Androgenetic Alopecia

Intervention

ARTAS™ System

Study Arms / Comparison Groups

 Computer-Assisted
Description:  Hair harvest using the computer-assisted system

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

37

Start Date

June 2009

Completion Date

September 2010

Primary Completion Date

September 2010

Eligibility Criteria

        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.
      

Gender

Male

Ages

30 Years - 59 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Miguel Canales, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00926211

Organization ID

RR-09-0002


Responsible Party

Sponsor

Study Sponsor

Restoration Robotics, Inc.


Study Sponsor

Miguel Canales, M.D., Study Director, Restoration Robotics


Verification Date

September 2011