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 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT05062733
Eligibility Criteria:
Inclusion Criteria:
* The patient is a man or a woman ≥ 18 years old at the time of inclusion.
* The patient is planned for a unilateral or bilateral gluteal implant placement with SEBBIN implants as per investigator decision
* The patient has been informed of the study, has read the patient informed consent and provided consent for the study in writing.
Exclusion Criteria:
* Patient implanted with silicone implants somewhere else in the body.
* Patient candidate for implantation with custom-designed implants.
* Participation in another interventional clinical study (participation into an observational study is permitted) with a medicinal product or a medical device in the 30 days prior to enrolment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05062733
Study Brief:
Protocol Section:
NCT05062733