Computer-Assisted Versus Manual Hair Harvest Comparative Study

Androgenetic Alopecia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00926211
• Other study ID #: RR-09-0002
• Status: Completed
• Phase: N/A
• First received: June 19, 2009
• Last updated: January 3, 2012
• Start date: June 2009
• Est. completion date: September 2010

Study information

• Verified date: September 2011
• Source: Restoration Robotics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 59 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alopecia
• Androgenetic Alopecia

Intervention

Device:
• ARTAS™ System
Hair harvest using a computer-assisted system

Procedure:
• Manual Hair Harvest
Hair harvesting via the manual technique

Locations

Country	Name	City	State
United States	Berman Skin Institute	Palo Alto	California
United States	A Practice of Hair Restoration	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Restoration Robotics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in Hair Follicles Present	The increase in the number of hair follicles present at follow-up in each region compared to the number present at baseline.	Change from Baseline at 9 Months	No
Secondary	Proportion of Harvested Follicles Transected	The proportion of harvested hair follicles that were transected by each harvest method.	Time of harvest (Baseline)	No