Recruiting

ARTAS System

Sponsor:

Venus Concept

Code:

NCT05938569

Conditions

Androgenic Alopecia

Eligibility Criteria

Sex: Male

Age: 20 - 70

Healthy Volunteers: Not accepted

Interventions

Hair restoration

Study Details

Brief summary:

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

Conditions

Androgenic Alopecia

Study ID

NCT05938569

Start date

Nov 3, 2016

Status verified date

Aug, 2024

Completion date

Dec 15, 2026

Anticipated

Primary completion date

Dec 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 20 - 70

Healthy Volunteers: Not accepted

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 Design

Enrollment

150 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: All subjects

The Study Treatment will involve follicular hair unit harvest, recipient site making, and implantation.

Interventions

Hair restoration

The Study Treatment will involve follicular hair unit harvest, recipient site making, and implantation.

Primary outcome measure

  • Change in Hair Density from pre to 12 months post-treatment in robotic vs manual implantation [ Time Frame: 1 year post-treatment ]

Central Contacts and Locations

Central contacts

Director of Clinical Affairs, PhD

8889070115mgronski@venusconcept.com

Locations

Le's Aesthetics

Recruiting

San Jose, California, United States, 95112

Contacts

Vincent Le, D.O.

408-835-9977vle02@yahoo.com

Lin Phong

408-835-9977infohaircenters@gmail.com

Principal Investigator:

Vincent Le

More Information

Sponsor

Venus Concept

Last update posted

Aug 26, 2024

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Venus Concept on 2024-08-26.