Alopecia
Conditions
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.
Interventions
DEVICEHairstetics hair implant device
Sponsors
Hairstetics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acceptable number, duration and severity of expected adverse device/procedure effects | 3 months following implantation |
Countries
France, India, Romania, United Kingdom
Contacts
Primary ContactIgal Ruvinsky, PhD
Backup ContactBoaz Shenhav
Outcome results
None listed