Computer-Assisted Versus Manual Hair Harvest Comparative Study
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|ClinicalTrials.gov Identifier: NCT00926211|
Recruitment Status : Completed
First Posted : June 23, 2009
Results First Posted : December 8, 2011
Last Update Posted : January 5, 2012
|Condition or disease||Intervention/treatment||Phase|
|Androgenetic Alopecia||Device: ARTAS™ System Procedure: Manual Hair Harvest||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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
- 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.
- Proportion of Harvested Follicles Transected [ Time Frame: Time of harvest (Baseline) ]The proportion of harvested hair follicles that were transected by each harvest method.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00926211
|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|