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:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT03194269
Eligibility Criteria:
Inclusion Criteria:
* Subjects who have ear prominence and/or have significant asymmetry
Exclusion Criteria:
* Subjects planning to use EARFOLD® in conjunction with other procedures (e.g. cartilage scoring, conchal reduction or concho-mastoid sutures) for correction of prominent ears are excluded
* Patients with impaired healing (e.g., current smokers, diabetic patients, patients with autoimmune disorders such as Ehlers-Danlos Syndrome or Scleroderma)
* Patients with an active infection, local or systemic
* Patients with known nickel or gold allergies.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Study:
NCT03194269
Study Brief:
Protocol Section:
NCT03194269