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Procedure

Robotic Hair Restoration for Male Pattern Baldness

N/A
Recruiting
Research Sponsored by Venus Concept
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
Subject has prior history of scalp reduction surgery(s) in the past six months
Subject has bleeding diathesis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a robotic system for hair restoration procedures at multiple clinics.

Who is the study for?
This trial is for men aged 20 to 70 with male pattern baldness (Norwood-Hamilton grade III-VI). Participants must be willing to cut their hair short for the procedure and agree to follow-up appointments. Men who've had scalp reduction surgery in the last six months, have bleeding disorders, or are on blood thinners cannot join.
What is being tested?
The study is testing the ARTAS System's performance in hair restoration procedures. It's a forward-looking study across multiple centers where participants will undergo treatment with this computer-assisted technology.
What are the potential side effects?
While not explicitly listed, potential side effects may include discomfort at harvest/implant sites, temporary swelling or bruising, infection risk, and dissatisfaction with aesthetic outcomes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 20 and 70 years old.
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I agree to cut my hair short in certain areas for the study.
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I am a man with moderate to severe hereditary hair loss.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had scalp reduction surgery in the last 6 months.
Select...
I have a bleeding disorder.
Select...
I am currently taking blood thinners.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: All subjectsExperimental Treatment1 Intervention
The Study Treatment will involve follicular hair unit harvest, recipient site making, and implantation.

Find a Location

Who is running the clinical trial?

Venus ConceptLead Sponsor
34 Previous Clinical Trials
1,174 Total Patients Enrolled

Media Library

ARTAS System (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05938569 — N/A
Male Pattern Baldness Research Study Groups: All subjects
Male Pattern Baldness Clinical Trial 2023: ARTAS System Highlights & Side Effects. Trial Name: NCT05938569 — N/A
ARTAS System (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05938569 — N/A
Male Pattern Baldness Patient Testimony for trial: Trial Name: NCT05938569 — N/A
~30 spots leftby Dec 2026
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