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

NCT ID: NCT02914587

Last Updated: 2017-02-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2017-10-31

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.

Conditions

Androgenic Alopecia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ARTAS System

Implantation with the ARTAS System.

Group Type: EXPERIMENTAL

ARTAS System

Intervention Type: DEVICE

Manual Implantation

Implantation manually.

Group Type: ACTIVE_COMPARATOR

Manual Implantation

Intervention Type: OTHER

Interventions

ARTAS System

Intervention Type: DEVICE

Manual Implantation

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 29 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Restoration Robotics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Berman Skin Institute

Palo Alto, California, United States

Countries

United States

Other Identifiers

CP-003

Identifier Type: -

Identifier Source: org_study_id