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 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
NCT ID:
NCT03356132
Eligibility Criteria:
Inclusion Criteria:
* provide written informed consent.
* female at birth
* be 18 years of age or older
* have received breast implant(s) for indication of primary or secondary augmentation until 21 days before (including the visit window)
* having received a breast implant with a textured surface or a breast implant with a surface coated with Silimed® polyurethane foam
* ability to comply with the protocol throughout the follow-up period.
Exclusion Criteria:
* mammary reconstruction in at least one breast or augmentation after previous reconstruction,
* pregnancy informed or breastfeeding at the inclusion moment,
* advanced fibrocystic disease at the time of implantation,
* neoplasia of any type not yet treated or being treated at the time of implantation, infection in activity not yet treated or being treated at any site at the time of implantation,
* reporting or recording of adverse reactions or intolerance to polyurethane or silicone prior to implantation,
* immune diseases affecting active connective tissue or (eg, lupus erythematosus, discoid lupus, scleroderma, etc.) at the time of implantation,
* signs of inflammation of the breast or implant site at the time of implantation,
* Increased risk of immediate postoperative complications due to use of illicit drugs or medications,
* Increased risk of immediate post-surgical complications caused by illicit drug use or medication use,
* have participated in another clinical study up to 6 months prior to the placement of the implant,
* any other condition which, based on the opinion of the investigator or designee, may prevent the provision of informed consent, renders participation in the study is unsafe, compromises adherence to the protocol, complicates the interpretation of data from the study outcome, or otherwise interferes with the achievement of study objectives.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03356132
Study Brief:
Protocol Section:
NCT03356132