Back to resultsComputer-Assisted Hair Implantation Using ARTAS System VS Manual Implantation Technique Hair Restoration Study
Primary Purpose
Androgenic Alopecia
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ARTAS System
Manual Implantation
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 IV-VI;
- Subject is 29 to 70 years old;
- Subject has black or brown hair color;
- Subject has straight hair;
- Subject agrees to cut hair short (about 1-1.4 mm) on the scalp in the designated study areas for harvesting and implantation;
- Subject agrees to have 6 dot tattoos placed on scalp;
- Subject is able to understand and provide written consent; and
- Subject consents to post-operative follow-up per protocol.
Exclusion Criteria:
- Subject has prior history of scalp reduction surgery(s);
- Subject has prior history of hair restoration procedure(s) using the strip excision technique;
- Subject has bleeding diathesis;
- Subject has active use of anti-coagulation medication;
- Subject has used finasteride in the previous 6 months, or plans to use finasteride during the study;
- Subject has used minoxidil in the previous 2 weeks, or plans to use minoxidil during the study; or
- 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 Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ARTAS System
Manual Implantation
Arm Description
Implantation with the ARTAS System.
Implantation manually.
Outcomes
Primary Outcome Measures
Hair Survival rate 9-months post procedure
Hair survival rate
Secondary Outcome Measures
Full Information
NCT ID
NCT02914587
First Posted
September 19, 2016
Last Updated
February 9, 2017
Sponsor
Restoration Robotics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02914587
Brief Title
Computer-Assisted Hair Implantation Using ARTAS System VS Manual Implantation Technique Hair Restoration Study
Official Title
Computer-Assisted Hair Implantation Using ARTAS System VS Manual Implantation Technique Hair Restoration Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
October 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Restoration Robotics, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To investigate and compare the safety and effectiveness of the ARTAS™ System to manual hair follicle implantation method following a nine month period of post-procedure evaluation.
Detailed Description
This comparative study is a multi-center, prospective, blinded, randomized controlled clinical study where subjects act as their own control.
The purpose of this study is to demonstrate that the ARTAS System is safe and effective for implanting follicular hair units.
Patients will be followed for a nine months period of time.
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
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ARTAS System
Arm Type
Experimental
Arm Description
Implantation with the ARTAS System.
Arm Title
Manual Implantation
Arm Type
Active Comparator
Arm Description
Implantation manually.
Intervention Type
Device
Intervention Name(s)
ARTAS System
Intervention Type
Other
Intervention Name(s)
Manual Implantation
Primary Outcome Measure Information:
Title
Hair Survival rate 9-months post procedure
Description
Hair survival rate
Time Frame
9 month
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
29 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 IV-VI;
Subject is 29 to 70 years old;
Subject has black or brown hair color;
Subject has straight hair;
Subject agrees to cut hair short (about 1-1.4 mm) on the scalp in the designated study areas for harvesting and implantation;
Subject agrees to have 6 dot tattoos placed on scalp;
Subject is able to understand and provide written consent; and
Subject consents to post-operative follow-up per protocol.
Exclusion Criteria:
Subject has prior history of scalp reduction surgery(s);
Subject has prior history of hair restoration procedure(s) using the strip excision technique;
Subject has bleeding diathesis;
Subject has active use of anti-coagulation medication;
Subject has used finasteride in the previous 6 months, or plans to use finasteride during the study;
Subject has used minoxidil in the previous 2 weeks, or plans to use minoxidil during the study; or
Subject has any other condition that, in the opinion of the investigator, makes the subject inappropriate to take part in this study.
Facility Information:
Facility Name
Berman Skin Institute
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Computer-Assisted Hair Implantation Using ARTAS System VS Manual Implantation Technique Hair Restoration Study
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