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RecruitingNCT05938569Updated Aug 26, 2024

Computer-Assisted Hair Restoration Study Using ARTAS System

An interventional study of Hair restoration in Androgenic Alopecia, sponsored by Venus Concept. Recruiting at 2 sites in United States. Open to male participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-08-26.

Sponsored by Venus Concept · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
20 Years to 70 Years
Sex
Male
01

Study summary

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

02

Conditions studied

  • Androgenic Alopecia

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03

In context

Alopecia

511 studies on the registry are indexed under Alopecia; 128 are open to participants now.

This study's planned enrollment of 150 is above the median of 50 across 430 interventional studies indexed under Alopecia.

Browse Alopecia studies →

Lead sponsor

Venus Concept is the lead sponsor of 34 studies on the registry; 4 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 12 (92%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    All subjects

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

    Device: Hair restoration

Interventions

  • DeviceHair restoration

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

06

What researchers measure

Primary outcomes

  1. Change in Hair Density from pre to 12 months post-treatment in robotic vs manual implantation

    Time frame: 1 year post-treatment

Secondary outcomes

  1. Percentage of follicles successfully harvested by Robot

    Time frame: 1 year post-treatment

07

Study locations

1 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05938569
Lead sponsor
Venus Concept
Responsible party
Sponsor
First posted
Jul 10, 2023
Start date
Nov 3, 2016
Primary completion
Dec 15, 2026 (estimated)
Completion
Dec 15, 2026 (estimated)
Last update
Aug 26, 2024

Study contacts

Director of Clinical Affairs, PhD
Contact
mgronski@venusconcept.com
8889070115

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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