Palo Alto, California 94304

  • Androgenic Alopecia

Purpose:

To investigate and compare the safety and effectiveness of the ARTAS™ System to manual hair follicle implantation method following a nine month period of post-procedure evaluation.


Study summary:

This comparative study is a multi-center, prospective, blinded, randomized controlled clinical study where subjects act as their own control. The purpose of this study is to demonstrate that the ARTAS System is safe and effective for implanting follicular hair units. Patients will be followed for a nine months period of time.


Criteria:

Inclusion Criteria: - Subject is male with clinical diagnosis of androgenetic alopecia with Norwood-Hamilton grade of IV-VI; - Subject is 29 to 70 years old; - Subject has black or brown hair color; - Subject has straight hair; - Subject agrees to cut hair short (about 1-1.4 mm) on the scalp in the designated study areas for harvesting and implantation; - Subject agrees to have 6 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 prior history of scalp reduction surgery(s); - Subject has prior history of hair restoration procedure(s) using the strip excision technique; - 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.


NCT ID:

NCT02914587


Primary Contact:

Raymond Lee
Phone: (408) 883-6760
Email: rayl@restorationrobotics.com


Backup Contact:

Email: judita@restorationrobotics.com
:Judit Adorjan
Phone: 6507221119


Location Contact:

Palo Alto, California 94304
United States

David Berman

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 17, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.