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Hairstetics Hair Implant Device Safety and Efficacy

Primary Purpose

Alopecia

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Hairstetics hair implant device
Sponsored by
Hairstetics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Alopecia

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subject is ≥ 19 years old.
  2. Subject has hair loss and has chosen to undergo synthetic hair implantation.
  3. Subject has mental capacity to understand study guidelines and requirements (to maintain scalp hygiene, use of shampoo, delicate combing, etc.).
  4. Subject has been evaluated by the investigator to have a scalp condition in the planned area of implantation that is acceptable for entering the study and currently is NOT suffering from skin problems at planned implantation site or elsewhere that might affect the procedure and/or success as clinically evaluated by the investigator.
  5. Subject has Good general health.
  6. Woman of child bearing potential must have a negative pregnancy test.
  7. Subject willing to sign a written informed consent form (ICF) and the post implantation maintenance protocol.

Exclusion Criteria:

  1. Previous synthetic hair implantation or hair transplantation in the past 6 months.
  2. Currently suffering from skin problems at planned implantation site or elsewhere that might affect the procedure and/or success as clinically evaluated by the investigator.
  3. Currently receiving or have within the past 3 months received radiation- and/or chemotherapy.
  4. Currently using steroid product with Immunosuppressive treatment.
  5. Impaired coagulation.
  6. Serious illness that may affect subject compliance to protocol.
  7. Subject is using illegal drugs.
  8. Participating in other clinical study.
  9. Known allergy or hypersensitivity to Nitinol or Nickel or Titanium
  10. For woman: Pregnancy or breast feeding.
  11. Known allergy or intolerance for the prescribed antibiotics and in such a case, a different antibiotics for which the subject is not allergic or intolerance to, will be prescribed

Sites / Locations

  • Cabinet du Dr G. BeilinRecruiting
  • Cabinet médical du Dr Jack SmadjaRecruiting
  • Georges Mandel Office Surgery ClinicRecruiting
  • Paras hospitalRecruiting
  • Fortis HospitalRecruiting
  • EgoclinicRecruiting
  • Metropolitan hospitalRecruiting
  • Revere clinicRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hairstetics hair implant device

Arm Description

Subjects will undergo the Hairstetics prosthetic hair implantation starting with a test of up to 100 fibers and up to 2 additional implantation sessions with up to 1500 fibers overall per subject. The implantation will be carried out according to the device IFU.

Outcomes

Primary Outcome Measures

Acceptable number, duration and severity of expected adverse device/procedure effects

Secondary Outcome Measures

Full Information

First Posted
July 7, 2016
Last Updated
August 8, 2017
Sponsor
Hairstetics
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1. Study Identification

Unique Protocol Identification Number
NCT02856308
Brief Title
Hairstetics Hair Implant Device Safety and Efficacy
Official Title
Safety and Efficacy Evaluation of Hairstetics Hair Implant in Subjects Affected With Hair Loss - a Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hairstetics

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a prospective, single-arm, multi-center, international, open-label, non-randomized, clinical study. The aim of the study is to assess the safety and efficacy of the use of the Hairstetics hair implant device in subjects affected with hair loss.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hairstetics hair implant device
Arm Type
Experimental
Arm Description
Subjects will undergo the Hairstetics prosthetic hair implantation starting with a test of up to 100 fibers and up to 2 additional implantation sessions with up to 1500 fibers overall per subject. The implantation will be carried out according to the device IFU.
Intervention Type
Device
Intervention Name(s)
Hairstetics hair implant device
Primary Outcome Measure Information:
Title
Acceptable number, duration and severity of expected adverse device/procedure effects
Time Frame
3 months following implantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is ≥ 19 years old. Subject has hair loss and has chosen to undergo synthetic hair implantation. Subject has mental capacity to understand study guidelines and requirements (to maintain scalp hygiene, use of shampoo, delicate combing, etc.). Subject has been evaluated by the investigator to have a scalp condition in the planned area of implantation that is acceptable for entering the study and currently is NOT suffering from skin problems at planned implantation site or elsewhere that might affect the procedure and/or success as clinically evaluated by the investigator. Subject has Good general health. Woman of child bearing potential must have a negative pregnancy test. Subject willing to sign a written informed consent form (ICF) and the post implantation maintenance protocol. Exclusion Criteria: Previous synthetic hair implantation or hair transplantation in the past 6 months. Currently suffering from skin problems at planned implantation site or elsewhere that might affect the procedure and/or success as clinically evaluated by the investigator. Currently receiving or have within the past 3 months received radiation- and/or chemotherapy. Currently using steroid product with Immunosuppressive treatment. Impaired coagulation. Serious illness that may affect subject compliance to protocol. Subject is using illegal drugs. Participating in other clinical study. Known allergy or hypersensitivity to Nitinol or Nickel or Titanium For woman: Pregnancy or breast feeding. Known allergy or intolerance for the prescribed antibiotics and in such a case, a different antibiotics for which the subject is not allergic or intolerance to, will be prescribed
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Igal Ruvinsky, PhD
Phone
+972-72-2501630
Email
igal.r@hairstetics.com
First Name & Middle Initial & Last Name or Official Title & Degree
Boaz Shenhav
Phone
+972-72-2501630
Email
boaz.s@hairstetics.com
Facility Information:
Facility Name
Cabinet du Dr G. Beilin
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ghislaine Beilin, MD
Facility Name
Cabinet médical du Dr Jack Smadja
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jack Smadja, MD
Facility Name
Georges Mandel Office Surgery Clinic
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Divaris, MD
Facility Name
Paras hospital
City
Gurgaon
ZIP/Postal Code
122002
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anil Ganjoo, MD
Facility Name
Fortis Hospital
City
New Delhi
ZIP/Postal Code
110088
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manjul Agrawal, MD
Facility Name
Egoclinic
City
Bucharest
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irinel Nedelcu, MD
Facility Name
Metropolitan hospital
City
Bucharest
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Radu Jecan, MD
Facility Name
Revere clinic
City
London
ZIP/Postal Code
W1G7JA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sach Mohan, MD

12. IPD Sharing Statement

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Hairstetics Hair Implant Device Safety and Efficacy

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