Computer-Assisted Hair Restoration Study Using ARTAS System | NCT05938569

Studies
Computer-Assisted Hair Restoration Study Using ARTAS System

NCT05938569

Sponsor

Venus Concept

Status

Recruiting

Last Update Posted

Aug 26, 2024Actual

Enrollment

150Estimated

Phase

Not Applicable

Conditions

Androgenic Alopecia

Interventions

Hair restoration

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 3, 2016

Primary Completion Date

Dec 15, 2026Estimated

Completion Date

Dec 15, 2026Estimated

First Submitted Date

Jun 27, 2023

First Submission Date that Met QC Criteria

Jul 5, 2023

First Posted Date

Jul 10, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 22, 2024

Last Update Posted Date

Aug 26, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
All subjects	Experimental	The Study Treatment will involve follicular hair unit harvest, recipient site making, and implantation.	Device: Hair restoration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hair restoration	Device	The Study Treatment will involve follicular hair unit harvest, recipient site making, and implantation.	All subjects

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Director of Clinical Affairs, PhD	Contact	8889070115		mgronski@venusconcept.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Berman Skin Institute	Completed	Los Altos	California	94022	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000505	Alopecia

Ancestor Terms

ID	Term
D007039	Hypotrichosis
D006201	Hair Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided