Hairstetics Hair Implant Device Safety and Efficacy

Not Applicable

• Conditions: Alopecia
• Interventions: Device: Hairstetics hair implant device

• Registration Number: NCT02856308
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2016-07-07
• Study First Submitted QC: 2016-08-01
• Study First Posted: 2016-08-04
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-08
• Last Update Posted: 2017-08-09
• Primary Completion: 2018-03
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hairstetics hair implant device	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.

Primary Outcome Measures

Name	Time	Method
Acceptable number, duration and severity of expected adverse device/procedure effects	3 months following implantation

Trial Locations

Locations (8)

Georges Mandel Office Surgery Clinic; 🇫🇷 Paris, France

Cabinet du Dr G. Beilin; 🇫🇷 Paris, France

Cabinet médical du Dr Jack Smadja; 🇫🇷 Paris, France

Revere clinic; 🇬🇧 London, United Kingdom

Metropolitan hospital; 🇷🇴 Bucharest, Romania

Egoclinic; 🇷🇴 Bucharest, Romania

Fortis Hospital; 🇮🇳 New Delhi, India

Paras hospital; 🇮🇳 Gurgaon, India