Back to resultsComputer-Assisted Hair Restoration Study Using ARTAS System
Primary Purpose
Androgenic Alopecia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hair restoration
Sponsored by
About this trial
This is an interventional treatment trial for Androgenic Alopecia
Eligibility 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
Sites / Locations
- Berman Skin InstituteRecruiting
- Le's AestheticsRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All subjects
Arm Description
The Study Treatment will involve follicular hair unit harvest, recipient site making, and implantation.
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05938569
Brief Title
Computer-Assisted Hair Restoration Study Using ARTAS System
Official Title
Computer-Assisted Hair Restoration Study Using ARTAS System
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 3, 2016 (undefined)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Venus Concept
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Prospective, multi-center, up to 4 investigational centers evaluating the performance of the ARTAS System in Hair Restoration Procedures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenic Alopecia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
All subjects
Arm Type
Experimental
Arm Description
The Study Treatment will involve follicular hair unit harvest, recipient site making, and implantation.
Intervention Type
Device
Intervention Name(s)
Hair restoration
Intervention Description
The Study Treatment will involve follicular hair unit harvest, recipient site making, and implantation.
Primary Outcome Measure Information:
Title
Change in Hair Density from pre to 12 months post-treatment in robotic vs manual implantation
Time Frame
1 year post-treatment
Secondary Outcome Measure Information:
Title
Percentage of follicles successfully harvested by Robot
Time Frame
1 year post-treatment
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Director of Clinical Affairs, PhD
Phone
8889070115
Email
mgronski@venusconcept.com
Facility Information:
Facility Name
Berman Skin Institute
City
Los Altos
State/Province
California
ZIP/Postal Code
94022
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Berman, M.D.
Phone
650-325-6000
Email
david.berman@skinmds.com
First Name & Middle Initial & Last Name & Degree
Anna Marte
Phone
(650) 325-6000
Email
anna.marte@skinmds.com
First Name & Middle Initial & Last Name & Degree
David Berman, M.D.
Facility Name
Le's Aesthetics
City
San Jose
State/Province
California
ZIP/Postal Code
95112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent Le, D.O.
Phone
408-835-9977
Email
vle02@yahoo.com
First Name & Middle Initial & Last Name & Degree
Lin Phong
Phone
408-835-9977
Email
infohaircenters@gmail.com
First Name & Middle Initial & Last Name & Degree
Vincent Le
12. IPD Sharing Statement
Plan to Share IPD
No
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Computer-Assisted Hair Restoration Study Using ARTAS System
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