Clinical trial NCT00926211: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Androgenetic Alopecia
Lead sponsor: Restoration Robotics, Inc.
Sponsor class: INDUSTRY
First posted: 2009-06-23
Enrollment: 37
Sex: MALE
Minimum age (years): 30
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Increase in Hair Follicles Present
timeFrame: Change from Baseline at 9 Months
Secondary outcomes:
measure: Proportion of Harvested Follicles Transected
timeFrame: Time of harvest (Baseline)
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Berman Skin Institute
state: California
city: Walnut Creek
country: United States
facility: A Practice of Hair Restoration
state: California
Study officials:
affiliation: Restoration Robotics
name: Miguel Canales, M.D.
role: STUDY_DIRECTOR
References: