Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2014-03-31
2018-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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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.
Hairstetics hair implant device
Interventions
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Hairstetics hair implant device
Eligibility Criteria
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Inclusion Criteria
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
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
19 Years
ALL
No
Sponsors
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Hairstetics
INDUSTRY
Responsible Party
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Locations
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Cabinet du Dr G. Beilin
Paris, , France
Cabinet médical du Dr Jack Smadja
Paris, , France
Georges Mandel Office Surgery Clinic
Paris, , France
Paras hospital
Gurgaon, , India
Fortis Hospital
New Delhi, , India
Egoclinic
Bucharest, , Romania
Metropolitan hospital
Bucharest, , Romania
Revere clinic
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Ghislaine Beilin, MD
Role: primary
Jack Smadja, MD
Role: primary
Marc Divaris, MD
Role: primary
Anil Ganjoo, MD
Role: primary
Manjul Agrawal, MD
Role: primary
Irinel Nedelcu, MD
Role: primary
Radu Jecan, MD
Role: primary
Sach Mohan, MD
Role: primary
Other Identifiers
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HET-03
Identifier Type: -
Identifier Source: org_study_id
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