Computer-Assisted Versus Manual Hair Harvest Comparative 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.
|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|
- 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.
- 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.
|Study Start Date:||June 2009|
|Study Completion Date:||September 2010|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
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
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.
|United States, California|
|Berman Skin Institute|
|Palo Alto, California, United States, 94304|
|A Practice of Hair Restoration|
|Walnut Creek, California, United States, 94596|
|Study Director:||Miguel Canales, M.D.||Restoration Robotics|