Computer-Assisted Hair Restoration Study Using ARTAS System

NCT ID: NCT05938569

Last Updated: 2024-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-03

Study Completion Date

2026-12-15

Brief Summary

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

Detailed Description

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Conditions

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Androgenic Alopecia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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All subjects

The Study Treatment will involve follicular hair unit harvest, recipient site making, and implantation.

Group Type EXPERIMENTAL

Hair restoration

Intervention Type DEVICE

The Study Treatment will involve follicular hair unit harvest, recipient site making, and implantation.

Interventions

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Hair restoration

The Study Treatment will involve follicular hair unit harvest, recipient site making, and implantation.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Venus Concept

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Berman Skin Institute

Los Altos, California, United States

Site Status COMPLETED

Le's Aesthetics

San Jose, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Director of Clinical Affairs, PhD

Role: CONTACT

8889070115

Facility Contacts

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Vincent Le, D.O.

Role: primary

408-835-9977

Lin Phong

Role: backup

408-835-9977

Other Identifiers

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CP-017

Identifier Type: -

Identifier Source: org_study_id

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