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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year post-treatment
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am between 20 and 70 years old.
Select...
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Hair Density from pre to 12 months post-treatment in robotic vs manual implantation
Secondary outcome measures
Percentage of follicles successfully harvested by Robot

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
1,192 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are older individuals eligible to join this study?

"This research is targeting individuals of at least 20 years or younger than 70."

Answered by AI

What is the cap for enrolment in this clinical investigation?

"Affirmative, the records on clinicaltrials.gov state that this experiment is currently recruiting volunteers. This study was originally posted online on November 3rd 2016 and has most recently been updated on July 5th 2023. 150 people need to be recruited from 2 different sites."

Answered by AI

Are there any vacancies available in this clinical trial?

"According to the information hosted on clinicaltrials.gov, this experiment is actively seeking participants. It was initially posted in November 2016 and has since been revised as of July 2023."

Answered by AI

Is it possible for me to register in this experiment?

"Prospective enrollees must possess male pattern baldness and fit between the age range of 20-70. At present, approximately 150 individuals are being sought for this trial."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
0
What state do they live in?
Pennsylvania
What site did they apply to?
Berman Skin Institute
Le's Aesthetics

Why did patients apply to this trial?

I am. Living pakistan tell me pakistani clinic address. I’m trying to reverse half a lifetime of male pattern baldness.
PatientReceived 1 prior treatment
I’ve tried pretty much everything and am not sure anything else will work!
PatientReceived no prior treatments
I've been experiencing hair thinning and hair loss and I would like to act before it gets too late.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Computer-Assisted Hair Restoration Study Using ARTAS System
2016. "Computer-Assisted Hair Restoration Study Using ARTAS System". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05938569.
All > Androgenetic Alopecia > Alopecia
~12 spots leftby Dec 2024
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