Computer-Assisted Hair Implantation Using ARTAS System VS Manual Implantation Technique Hair Restoration Study

Not Applicable

• Conditions: Androgenic Alopecia
• Interventions: Other: Manual Implantation; Device: ARTAS System

• Registration Number: NCT02914587
• Lead Sponsor: Restoration Robotics, Inc.

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 Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-09-19
• Study First Submitted QC: 2016-09-23
• Study First Posted: 2016-09-26
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-09
• Last Update Posted: 2017-02-13
• Primary Completion: 2017-10
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Manual Implantation	Manual Implantation	Implantation manually.
ARTAS System	ARTAS System	Implantation with the ARTAS System.

Primary Outcome Measures

Name	Time	Method
Hair Survival rate 9-months post procedure	9 month	Hair survival rate

Trial Locations

Locations (1)

Berman Skin Institute; 🇺🇸 Palo Alto, California, United States