Computer-Assisted Hair Restoration Study Using ARTAS System

Prospective, multi-center, up to 4 investigational centers evaluating the performance of the ARTAS System in Hair Restoration Procedures.

Study Overview

• Status: Recruiting
• Conditions: Androgenic Alopecia
• Intervention / Treatment: Device: Hair restoration

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Director of Clinical Affairs, PhD; Phone Number: 8889070115; Email: mgronski@venusconcept.com

Study Locations

• United States
  • California
    • Los Altos, California, United States, 94022
      • Completed
      • Berman Skin Institute
    • San Jose, California, United States, 95112
      • Recruiting
      • Le's Aesthetics
      • Contact: Vincent Le, D.O.; Phone Number: 408-835-9977; Email: vle02@yahoo.com
      • Contact: Lin Phong; Phone Number: 408-835-9977; Email: infohaircenters@gmail.com
      • Principal Investigator: Vincent Le

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subject is male with clinical diagnosis of androgenetic alopecia with Norwood-Hamilton grade of III-VI
• Subject is 20 to 70 years old
• Subject agrees to cut hair short (< 1 mm) on the scalp in the designated study areas for harvesting and implantation
• Subject is able to understand and provide written consent
• Subject consents to post-operative follow-up per protocol

Exclusion Criteria:

• Subject has prior history of scalp reduction surgery(s) in the past six months
• Subject has bleeding diathesis
• Subject has active use of anti-coagulation medication
• 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: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All subjects; The Study Treatment will involve follicular hair unit harvest, recipient site making, and implantation.	Device: Hair restoration; The Study Treatment will involve follicular hair unit harvest, recipient site making, and implantation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Hair Density from pre to 12 months post-treatment in robotic vs manual implantation	1 year post-treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of follicles successfully harvested by Robot	1 year post-treatment

Collaborators and Investigators

• Sponsor: Venus Concept

Study record dates

Study Major Dates

• Study Start: November 3, 2016
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026

Study Registration Dates

• First Submitted: June 27, 2023
• First Submitted That Met QC Criteria: July 5, 2023
• First Posted (Actual): July 10, 2023

Study Record Updates

• Last Update Posted (Actual): August 26, 2024
• Last Update Submitted That Met QC Criteria: August 22, 2024
• Last Verified: August 1, 2024

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-017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes