Clinical trial NCT02856308: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Alopecia
Lead sponsor: Hairstetics
Sponsor class: INDUSTRY
First posted: 2016-08-04
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: Acceptable number, duration and severity of expected adverse device/procedure effects
timeFrame: 3 months following implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Cabinet du Dr G. Beilin
city: Paris
country: France
facility: Cabinet médical du Dr Jack Smadja
city: Paris
country: France
facility: Georges Mandel Office Surgery Clinic
city: Gurgaon
country: India
facility: Paras hospital
city: New Delhi
country: India
facility: Fortis Hospital
city: Bucharest
country: Romania
facility: Egoclinic
city: Bucharest
country: Romania
facility: Metropolitan hospital
city: London
country: United Kingdom
facility: Revere clinic
Study officials:
References: