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

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 Overview

• Status: Unknown
• Conditions: Androgenic Alopecia
• Intervention / Treatment: Device: ARTAS System; Other: Manual Implantation

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Berman Skin Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 29 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ARTAS System; Implantation with the ARTAS System.	Device: ARTAS System
ACTIVE_COMPARATOR: Manual Implantation; Implantation manually.	Other: Manual Implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hair Survival rate 9-months post procedure	Hair survival rate	9 month

Collaborators and Investigators

• Sponsor: Restoration Robotics, Inc.

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (ANTICIPATED): October 1, 2017
• Study Completion (ANTICIPATED): October 1, 2017

Study Registration Dates

• First Submitted: September 19, 2016
• First Submitted That Met QC Criteria: September 23, 2016
• First Posted (ESTIMATE): September 26, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2017
• Last Update Submitted That Met QC Criteria: February 9, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia
• Other Study ID Numbers: CP-003