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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02914587
Other study ID # CP-003
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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