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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02856308 |
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Date of registration:
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07/07/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Hairstetics Hair Implant Device Safety and Efficacy
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Scientific title:
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Safety and Efficacy Evaluation of Hairstetics Hair Implant in Subjects Affected With Hair Loss - a Clinical Study |
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Date of first enrolment:
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March 2014 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02856308 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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India
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Romania
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United Kingdom
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Contacts
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Name:
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Igal Ruvinsky, PhD |
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Address:
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Telephone:
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+972-72-2501630 |
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Email:
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igal.r@hairstetics.com |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
19 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Alopecia
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Intervention(s)
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Device: Hairstetics hair implant device
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Primary Outcome(s)
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Acceptable number, duration and severity of expected adverse device/procedure effects
[Time Frame: 3 months following implantation]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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