NCT05938569

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Nov 2016Dec 2026

Study Start

First participant enrolled

November 3, 2016

Completed
6.6 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 10, 2023

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2026

Last Updated

August 26, 2024

Status Verified

August 1, 2024

Enrollment Period

10.1 years

First QC Date

June 27, 2023

Last Update Submit

August 22, 2024

Conditions

Androgenic Alopecia

Outcome Measures

Primary Outcomes (1)

  • Change in Hair Density from pre to 12 months post-treatment in robotic vs manual implantation

    1 year post-treatment

Secondary Outcomes (1)

  • Percentage of follicles successfully harvested by Robot

    1 year post-treatment

Study Arms (1)

All subjects

EXPERIMENTAL

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

Device: Hair restoration

Interventions

Hair restorationDEVICE

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

All subjects

Eligibility Criteria

Age20 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Berman Skin Institute

Los Altos, California, 94022, United States

COMPLETED

Le's Aesthetics

San Jose, California, 95112, United States

RECRUITING

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Director of Clinical Affairs, PhD

CONTACT

8889070115mgronski@venusconcept.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2023

First Posted

July 10, 2023

Study Start

November 3, 2016

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

December 15, 2026

Last Updated

August 26, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

US(2)