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Hairstetics Hair Implant Device Safety and Efficacy

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ClinicalTrials.gov Identifier: NCT02856308
Recruitment Status : Recruiting
First Posted : August 4, 2016
Last Update Posted : August 9, 2017
Sponsor:
Information provided by (Responsible Party):
Hairstetics

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.


Condition or disease Intervention/treatment Phase
Alopecia Device: Hairstetics hair implant device Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Safety and Efficacy Evaluation of Hairstetics Hair Implant in Subjects Affected With Hair Loss - a Clinical Study
Study Start Date : March 2014
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : September 2018

Arm Intervention/treatment
Experimental: Hairstetics hair implant device
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.
Device: Hairstetics hair implant device



Primary Outcome Measures :
  1. Acceptable number, duration and severity of expected adverse device/procedure effects [ Time Frame: 3 months following implantation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02856308


Contacts
Contact: Igal Ruvinsky, PhD +972-72-2501630 igal.r@hairstetics.com
Contact: Boaz Shenhav +972-72-2501630 boaz.s@hairstetics.com

Locations
France
Cabinet du Dr G. Beilin Recruiting
Paris, France
Contact: Ghislaine Beilin, MD         
Cabinet médical du Dr Jack Smadja Recruiting
Paris, France
Contact: Jack Smadja, MD         
Georges Mandel Office Surgery Clinic Recruiting
Paris, France
Contact: Marc Divaris, MD         
India
Paras hospital Recruiting
Gurgaon, India, 122002
Contact: Anil Ganjoo, MD         
Fortis Hospital Recruiting
New Delhi, India, 110088
Contact: Manjul Agrawal, MD         
Romania
Egoclinic Recruiting
Bucharest, Romania
Contact: Irinel Nedelcu, MD         
Metropolitan hospital Recruiting
Bucharest, Romania
Contact: Radu Jecan, MD         
United Kingdom
Revere clinic Recruiting
London, United Kingdom, W1G7JA
Contact: Sach Mohan, MD         
Sponsors and Collaborators
Hairstetics

Responsible Party: Hairstetics
ClinicalTrials.gov Identifier: NCT02856308     History of Changes
Other Study ID Numbers: HET-03
First Posted: August 4, 2016    Key Record Dates
Last Update Posted: August 9, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Alopecia
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical