Computer-Assisted Versus Manual Hair Harvest Comparative Study

• ClinicalTrials.gov Identifier: NCT00926211
• Recruitment Status: Completed
• First Posted: June 23, 2009
• Results First Posted: December 8, 2011
• Last Update Posted: January 5, 2012
• Sponsor: Restoration Robotics, Inc.
• Information provided by (Responsible Party): Restoration Robotics, Inc.

Study Description

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 Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• Ages Eligible for Study: 30 Years to 59 Years (Adult)
• Sexes 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

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

• Responsible Party: Restoration Robotics, Inc.
• ClinicalTrials.gov Identifier: NCT00926211
• Other Study ID Numbers: RR-09-0002
• First Posted: June 23, 2009
• Results First Posted: December 8, 2011
• Last Update Posted: January 5, 2012
• Last Verified: September 2011

Additional relevant MeSH terms:

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Pathological Conditions, Anatomical