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

Androgenic Alopecia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02914587
• Other study ID #: CP-003
• Status: Active, not recruiting
• Phase: N/A
• First received: September 19, 2016
• Last updated: February 9, 2017
• Start date: August 2016
• Est. completion date: October 2017

Study information

• Verified date: February 2017
• Source: Restoration Robotics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 29 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alopecia
• Androgenic Alopecia

Intervention

Device:
• ARTAS System

Other:
• Manual Implantation

Locations

Country	Name	City	State
United States	Berman Skin Institute	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Restoration Robotics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hair Survival rate 9-months post procedure	Hair survival rate	9 month