Robotic Hair Restoration for Male Pattern Baldness

Overseen By David Berman, M.D.

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Venus Concept

Must not be taking: Anti-coagulation

Disqualifiers: Scalp surgery, Bleeding diathesis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4-6 weeks

150 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are actively using anti-coagulation medication.

What data supports the effectiveness of the treatment ARTAS System, ARTAS Robotic Hair Restoration, ARTAS iX for male pattern baldness?

The ARTAS system uses robotic technology to precisely harvest hair grafts, which can lead to more natural-looking results in hair restoration. This system is used worldwide and is particularly effective due to its ability to analyze the donor area and accurately extract hair follicles. ^{1 2 3 4 5}

How is the ARTAS System treatment different from other treatments for male pattern baldness?

The ARTAS System is unique because it uses a robotic technology to precisely harvest hair follicles from the donor area, which can lead to more accurate and consistent results compared to manual methods. This system analyzes images of the scalp and uses a specialized needle and punch to extract hair follicles, making it a novel approach in hair restoration. ^{1 3 6 7 8}

What is the purpose of this trial?

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

Eligibility Criteria

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.

Inclusion Criteria

I am between 20 and 70 years old.

I agree to cut my hair short in certain areas for the study.

I am a man with moderate to severe hereditary hair loss.

Exclusion Criteria

I have had scalp reduction surgery in the last 6 months.

I have a bleeding disorder.

Subject has any other condition that, in the opinion of the investigator, makes the subject inappropriate to take part in this study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo follicular hair unit harvest, recipient site making, and implantation using the ARTAS System

4-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• ARTAS System

Trial Overview 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.

Participant Groups

Group I: All subjects Experimental Treatment 1 Intervention

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

ARTAS System is already approved in United States, European Union for the following indications:

Approved in United States as ARTAS iX for:

• Harvesting hair follicles from the scalp in men diagnosed with androgenic alopecia (male pattern hair loss) who have black or brown straight hair

Approved in European Union as ARTAS iX for:

• Harvesting hair follicles from the scalp in men diagnosed with androgenic alopecia (male pattern hair loss) who have black or brown straight hair

Who Is Running the Clinical Trial?

Venus Concept

Lead Sponsor

Trials

35

Recruited

1,300+

Findings from Research

The ARTAS robotic system enhances hair restoration surgery by using advanced imaging and a specialized technique to efficiently harvest follicular units, improving the precision of graft extraction.

This robotic technology offers advantages such as increased accuracy and consistency in the harvesting process, although it may also have some limitations compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic hair restoration. Rose, PT., Nusbaum, B.[2013]

Recent advancements in hair transplantation techniques have significantly improved the natural appearance of results, making it a leading area in aesthetic surgery.

The use of follicular unit grafts, combined with enhanced harvesting and implantation methods, showcases the integration of artistic skill and scientific understanding in achieving successful hair restoration outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hair transplantation surgery. Khanna, M.[2021]

The new hair-lifting technique for treating male-pattern alopecia involves removing segments of bald skin and lifting existing hair into the bald areas, which can also provide a partial face-lift benefit.

This procedure is performed in stages under local anesthesia and is particularly effective for specific types of baldness, such as tonsure baldness in men and skull-cap androgenic alopecia in women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obliteration of alopecia by hair-lifting: a new concept and technique. Blanchard, G., Blanchard, B.[2018]

A study involving 21 patients with cicatricial baldness demonstrated that a two-stage treatment combining scalp expansion and hair autografting was successful in all cases, effectively repairing bald areas up to 340 cm².

Despite minor complications, such as one expander exposure and changes in hair direction in two cases, the overall results indicate that this method is a viable and effective option for treating extensive cicatricial baldness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treating cicatricial baldness with scalp expanding and hair autografting]. Li, AL., Yu, MS., Yan, YZ.[2006]

The robotic system for hair restoration surgery demonstrated safety and efficiency, creating an average of 1,593 recipient sites per hour with a total of 36,273 sites made for 31 men with androgenetic alopecia.

Postoperative complications were generally mild, with the most common being crusting (54.8%), and patient satisfaction and cosmetic outcomes were high, averaging scores of 4.10 and 4.13 on a 5-point scale, indicating the procedure's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotically Assisted Recipient Site Preparation in Hair Restoration Surgery: Surgical Safety and Clinical Outcomes in 31 Consecutive Patients. Kanayama, K., Kato, H., Mori, M., et al.[2023]

Follicular unit transplantation is a revolutionary technique for hair restoration that effectively redistributes genetically stable hair, helping to restore a natural hairline and improve facial symmetry.

This method provides high-impact, natural-looking results with minimal downtime and low risk of adverse outcomes, making it a valuable option for male aesthetic facial rejuvenation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hair restoration. Rawnsley, JD.[2022]

Recent advancements in surgical techniques for male pattern baldness, such as punch autografts, strip grafting, and microsurgery, have significantly improved the effectiveness of hair restoration procedures.

The introduction of minigrafts and micrografts represents a refinement in hair transplantation, offering more options for patients seeking treatment for hair loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical procedures for the treatment of baldness. Stough, DB., Mendoza, F., Freilich, IW.[2013]

Hair restoration techniques have evolved significantly since Dr. Norman Orentreich's discovery that hair follicles from nonbalding areas can be successfully transplanted to balding areas, leading to natural-looking results.

Modern hair transplants now utilize follicular units instead of large plugs, allowing for more precise and undetectable outcomes in treating conditions like androgenetic alopecia, with ongoing advancements in surgical methods and growth enhancement techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The latest innovations in hair transplantation. Rose, PT.[2015]

References

1. United States pubmed.ncbi.nlm.nih.gov

Robotic hair restoration. [2013]

2. Germany pubmed.ncbi.nlm.nih.gov

Hair transplantation surgery. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Obliteration of alopecia by hair-lifting: a new concept and technique. [2018]

4. China pubmed.ncbi.nlm.nih.gov

[Treating cicatricial baldness with scalp expanding and hair autografting]. [2006]

5. United States pubmed.ncbi.nlm.nih.gov

Robotically Assisted Recipient Site Preparation in Hair Restoration Surgery: Surgical Safety and Clinical Outcomes in 31 Consecutive Patients. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Hair restoration. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Surgical procedures for the treatment of baldness. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

The latest innovations in hair transplantation. [2015]