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Computer-Assisted Hair Restoration Study Using ARTAS System

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ClinicalTrials.gov Identifier: NCT05938569
Recruitment Status : Recruiting
First Posted : July 10, 2023
Last Update Posted : July 10, 2023
Sponsor:
Information provided by (Responsible Party):
Venus Concept

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

Condition or disease Intervention/treatment Phase
Androgenic Alopecia Device: Hair restoration Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Computer-Assisted Hair Restoration Study Using ARTAS System
Study Start Date : November 3, 2016
Estimated Primary Completion Date : December 30, 2024
Estimated Study Completion Date : December 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: All subjects
The Study Treatment will involve follicular hair unit harvest, recipient site making, and implantation.
 Device: Hair restoration
The Study Treatment will involve follicular hair unit harvest, recipient site making, and implantation.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Hair Density from pre to 12 months post-treatment in robotic vs manual implantation [ Time Frame: 1 year post-treatment ]

Secondary Outcome Measures :
  1. Percentage of follicles successfully harvested by Robot [ Time Frame: 1 year post-treatment ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05938569


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

Locations
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United States, California
Berman Skin Institute Recruiting
Los Altos, California, United States, 94022
Contact: David Berman, M.D.    650-325-6000    david.berman@skinmds.com   
Contact: Anna Marte    (650) 325-6000    anna.marte@skinmds.com   
Principal Investigator: David Berman, M.D.         
Le's Aesthetics Recruiting
San Jose, California, United States, 95112
Contact: Vincent Le, D.O.    408-835-9977    vle02@yahoo.com   
Contact: Lin Phong    408-835-9977    infohaircenters@gmail.com   
Principal Investigator: Vincent Le         
Sponsors and Collaborators
Venus Concept
More Information
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Responsible Party: Venus Concept
ClinicalTrials.gov Identifier: NCT05938569    
Other Study ID Numbers: CP-017
First Posted: July 10, 2023    Key Record Dates
Last Update Posted: July 10, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Alopecia
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical