Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT02316418
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 19 yrs.
2. Female patients with androgenetic alopecia (FPHL).
3. Pre-treatment hematology and coagulation values within the limits:
1. Hemoglobin ≥ 10 g/dl (g/100 ml)
2. Platelets ≥ 150 x 10\^9/L (10\^3/mm\^3)
3. WBC ≥ 3.0 x 10\^9/L (10\^3/mm\^3)
4. INR 0.8 - 1.2 ---
5. PTT 25" - 35"
6. Serum creatinine \< 2 mg/dl
7. SGOT \< 1.5 x ULN (Upper Limit of Norm)
8. SGPT \< 1.5 x ULN
9. Alkaline phosphatase \< 1.5 x ULN
4. A life expectancy at least of the duration of the trial.
5. Signed informed consent and post-implantation protocol.
Exclusion Criteria:
1. Prosthetic hair implantation or hair transplantation in the 6 months preceding enrollment to this study.
2. Skin conditions that might affect the procedure and/or its outcome. NOTE: Such conditions are not necessarily restricted to or involve the prospective implantation site and/or its vicinity.
3. Patients currently receiving, or that have received within the past 3 months, radio- and/or chemotherapy.
4. Patients on anticoagulant treatment.
5. More than a maintenance dose of oral corticosteroids (maintenance dose is defined as the same dose regimen over the past 6 months for a condition requiring continual corticosteroid treatment) or patients with an immunocompromised state for any reason.
6. Bleeding disorder.
7. Patient presenting with a health condition that may affect compliance with the study protocol, either by itself or combined with other conditions present in the patient.
8. Use of illegal substances.
9. Participation in another interventional study, unless discussed with and approved by the Sponsor or Sponsor's authorized representative.
10. Quantitative β-HCG ≥ 5 mIU/mL (IU/L) in women of childbearing potential.
11. Lactating and/or breastfeeding women.
12. Known hypersensitivity (e.g., to nitinol, nickel or titanium) or adverse event that would prevent a prospective study participant from being administered the trial treatment or non-investigational medicinal product(s), as detailed in the protocol.
13. Patients with implanted electronic devices (such as cardiac pacemakers) unless they receive permission from their treating physician (e.g., cardiologist) and are monitored by a treating physician during the treatment session.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT02316418
Study Brief:
Protocol Section:
NCT02316418