Robotic Hair Restoration for Male Pattern Baldness
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Male
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Venus Concept
No Placebo Group
Approved in 2 jurisdictions
Trial Summary
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.
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.
12467What 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.
13578Will 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.
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.
I am currently taking blood thinners.
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: All subjectsExperimental Treatment1 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
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Le's AestheticsSan Jose, CA
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Who is running the clinical trial?
Venus ConceptLead Sponsor
References
Obliteration of alopecia by hair-lifting: a new concept and technique. [2018]A new concept and technique of treatment of male-pattern alopecia are described. The concept is to remove, in serial stages, segments of skin that measure about 3 cm by 7 to 10 cm from the bald area of an alopecic scalp, and to raise the remaining hairy portion into the previously bald area.The technique consists of undermining the skin in the normal plane of cleavage between the galea and the sub-aponeurotic loose connective tissue after each removal of bald skin and "lifting" of hairy skin into the operative defects as they are obliterated by primary closure. By this method, which we call hair-lifting, the patient benefits also from an associated partial face-lift. Whatever remains of baldness after as much hair-lifting as feasible has been performed, is filled with "punch" grafts or free or pedicled strips. Each stage of the procedure is done under local anesthesia. The entire procedure is particularly suitable for tonsure baldness in men and even in the skull-cap type of androgenic alopecia in women.
Surgical procedures for the treatment of baldness. [2013]New surgical methods are now available for the correction of male pattern baldness. Standard techniques have been significantly refined during the past decade. These methods include punch autografts, strip grafting, scalp reduction, use of hair-bearing flaps, microsurgery, and various combinations of these techniques. A more recent refinement of hair transplantation is the use of minigrafts and micrografts. We present an overview of the advantages and indications for each procedure.
[Treating cicatricial baldness with scalp expanding and hair autografting]. [2006]To investigate the effective method to treat cicatricial baldness.
Hair restoration. [2022]The impact of male hair loss as a personal and social marker of aging is tremendous and its persistence as a human concern throughout recorded history places it in the forefront of male concern about the physical signs of aging. Restoration of the frontal hairline has the visual effect of re-establishing facial symmetry and turning back time. Follicular unit transplantation has revolutionized hair restoration, with its focus on redistributing large numbers of genetically stable hair to balding scalp in a natural distribution. Follicular unit hair restoration surgery is a powerful tool for the facial plastic surgeon in male aesthetic facial rejuvenation because it offers high-impact, natural-appearing results with minimal downtime and risk for adverse outcome.
Hair transplantation surgery. [2021]Techniques in hair transplantation have evolved recently which make results look more natural. Hair restoration is one of the most exciting and innovative surgical fields in aesthetic surgery today. A precise appreciation of anatomy has allowed the use of follicular unit grafts. With better methods of harvesting and implantation, hair transplantation results represent a blend of art and science.
The latest innovations in hair transplantation. [2015]Hair restoration began as a result of the fortuitous finding by Dr. Norman Orentreich that hair follicles taken from an area of nonbalding scalp could be implanted into an area of male pattern hair loss and continue to grow terminal hair. Since that time, hair transplants have progressed from the use of large plugs to the use of follicular units (normally occurring clusters of hairs). This has allowed surgeons to create undetectable results in cases of androgenetic alopecia and well as other conditions associated with hair loss. Advances continue in hair restoration technique ranging from surgical approach to instrumentation and ways to enhance growth. In this article, the more recent surgical and medical innovations in hair reconstruction are reviewed.
Robotic hair restoration. [2013]The latest innovation to hair restoration surgery has been the introduction of a robotic system for harvesting grafts. This system uses the follicular unit extraction/follicular isolation technique method for harvesting follicular units, which is particularly well suited to the abilities of a robotic technology. The ARTAS system analyzes images of the donor area and then a dual-chamber needle and blunt dissecting punch are used to harvest the follicular units. The robotic technology is now being used in various locations around the world. This article discusses the use of the robotic system, its capabilities, and the advantages and disadvantages of the system.
Robotically Assisted Recipient Site Preparation in Hair Restoration Surgery: Surgical Safety and Clinical Outcomes in 31 Consecutive Patients. [2023]Recent advances in robotic surgery have extended to hair restoration surgery, using a robotic recipient site creation device.