Computer-Assisted Hair Restoration Study Using ARTAS System

July 5, 2023 updated by: Venus Concept
Prospective, multi-center, up to 4 investigational centers evaluating the performance of the ARTAS System in Hair Restoration Procedures.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Altos, California, United States, 94022
        • Recruiting
        • Berman Skin Institute
        • Contact:
        • Contact:
        • Principal Investigator:
          • David Berman, M.D.
      • San Jose, California, United States, 95112
        • Recruiting
        • Le's Aesthetics
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vincent Le

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Hair Density from pre to 12 months post-treatment in robotic vs manual implantation
Time Frame: 1 year post-treatment
1 year post-treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of follicles successfully harvested by Robot
Time Frame: 1 year post-treatment
1 year post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Venus Concept

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 3, 2016

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

June 27, 2023

First Submitted That Met QC Criteria

July 5, 2023

First Posted (Actual)

July 10, 2023

Study Record Updates

Last Update Posted (Actual)

July 10, 2023

Last Update Submitted That Met QC Criteria

July 5, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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