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 @ 9:41 PM
Ignite Modification Date:
2025-12-24 @ 9:41 PM
NCT ID:
NCT02438332
Eligibility Criteria:
Inclusion Criteria:
* Primary breast augmentation (either bilateral or unilateral) operated on by the investigating surgeon with an infra-mammary approach smooth or textured NATRELLE® INSPIRA® TruForm® 1 or 2 device
* Primary breast augmentation 2 to 4 years (24-48 months) prior to data collection
* Subfascial, submuscular, dual plane or subglandular implant placement
Exclusion Criteria:
* Breast augmentation for Poland Syndrome or amastia
* Breast reconstruction following mastectomy
* Revision or secondary breast reconstruction
* Non NATRELLE® INSPIRA® device implanted at initial breast augmentation
* Women diagnosed with breast disease considered to be pre-malignant or malignant prior to or at the time of primary breast augmentation
* Surgical procedures of the breast not related to the primary breast augmentation (e.g. excision of significant skin lesions or a biopsy) occurring prior to or at the time of primary augmentation that may adversely affect the aesthetic outcome in the opinion of the investigator
* Axillary or peri-areolar approach
* Mastopexy augmentation
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
22 Years
Study:
NCT02438332
Study Brief:
Protocol Section:
NCT02438332