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 @ 7:09 PM
Ignite Modification Date:
2025-12-24 @ 7:09 PM
NCT ID:
NCT04646057
Eligibility Criteria:
Inclusion Criteria:
* Female between the inclusive ages of 22 and 70 at the time of initial expander surgery
* Scheduled to undergo either unilateral or bilateral mastectomy with immediate 2-stage breast reconstruction
* Is able to understand the study requirements and is willing to provide written informed consent
* Is willing and able to return for all scheduled study visits
Exclusion Criteria:
* Is pregnant or planning to become pregnant during study participation
* Has a history of failed tissue expansion or breast implantation at the intended reconstruction site
* has a residual gross tumor at the intended reconstruction site
* has been treated for a systemic infection or a local infection at the surgical site that the investigator determines will affect the safety of the subject during breast reconstruction and/or mesh use
* has, as determined by the investigator, unsuitable tissue integrity for immediate 2-stage breast reconstruction
* has undergone previous radiation therapy to the reconstruction site or chest wall
* is scheduled to undergo post-operative radiation therapy at the reconstruction site
* has a Body Mass Index (BMI) \< 14 or \> 44
* has used nicotine products within 90 days of screening
* is currently taking medications including non-NSAID anti-coagulants, immunosuppressants (including systemic steroids), or other medications determined by the investigator to place the subject at an increased risk of local complications of breast reconstruction
* has been diagnosed with a comorbid condition determined by the investigator to place the subject at an increased risk of complications
* has participated in any other clinical study that the investigator feels may interfere with this clinical study
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
22 Years
Maximum Age:
70 Years
Study:
NCT04646057
Study Brief:
Protocol Section:
NCT04646057