NCT02914587UnknownNot Applicable
Computer-Assisted Hair Implantation Using ARTAS System VS Manual Implantation Technique Hair Restoration Study
Restoration Robotics, Inc.2 sites in 1 country32 target enrollmentStarted: August 1, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 32
- Locations
- 2
- Primary Endpoint
- Hair Survival rate 9-months post procedure
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 29 Years to 70 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Hair Survival rate 9-months post procedure
Time Frame: 9 month
Hair survival rate
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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