Computer-Assisted Versus Manual Hair Harvest Comparative Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Restoration Robotics, Inc.
ClinicalTrials.gov Identifier:
NCT00926211
First received: June 19, 2009
Last updated: January 3, 2012
Last verified: September 2011
  Purpose

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 Intervention
Androgenetic Alopecia
Device: ARTAS™ System
Procedure: Manual Hair Harvest

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Computer-Assisted vs. Manual Hair Follicle Harvest: A Comparative Hair Count Study

Resource links provided by NLM:


Further study details as provided by Restoration Robotics, Inc.:

Primary Outcome Measures:
  • Increase in Hair Follicles Present [ Time Frame: Change from Baseline at 9 Months ] [ Designated as safety issue: No ]
    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:
  • Proportion of Harvested Follicles Transected [ Time Frame: Time of harvest (Baseline) ] [ Designated as safety issue: No ]
    The proportion of harvested hair follicles that were transected by each harvest method.


Enrollment: 37
Study Start Date: June 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   30 Years to 59 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00926211

Locations
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.
Investigators
Study Director: Miguel Canales, M.D. Restoration Robotics
  More Information

No publications provided

Responsible Party: Restoration Robotics, Inc.
ClinicalTrials.gov Identifier: NCT00926211     History of Changes
Other Study ID Numbers: RR-09-0002
Study First Received: June 19, 2009
Results First Received: September 23, 2011
Last Updated: January 3, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 19, 2014