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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
History of Changes

June 19, 2009
January 3, 2012
June 2009
September 2010   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00926211 on ClinicalTrials.gov Archive Site
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.
Not Provided
Not Provided
Not Provided
 
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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Androgenetic Alopecia
  • Device: ARTAS™ System
    Hair harvest using a computer-assisted system
  • Procedure: Manual Hair Harvest
    Hair harvesting via the manual technique
  • Experimental: Computer-Assisted
    Hair harvest using the computer-assisted system
    Intervention: Device: ARTAS™ System
  • Active Comparator: Manual Harvest
    Hair harvesting via manual technique
    Intervention: Procedure: Manual Hair Harvest
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
September 2010
September 2010   (final data collection date for primary outcome measure)

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.
Male
30 Years to 59 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00926211
RR-09-0002
No
Restoration Robotics, Inc.
Restoration Robotics, Inc.
Not Provided
Study Director: Miguel Canales, M.D. Restoration Robotics
Restoration Robotics, Inc.
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP