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 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT01959867
Eligibility Criteria:
Inclusion Criteria:
* Patient is at least 18 years of age
* Patient is female
* Patient is undergoing immediate, two-stage breast reconstruction following mastectomy with or without the use of SurgiMend® PRS
* Patient has previously undergone pre-mastectomy XRT for breast cancer, with lumpectomy or partial mastectomy, with the previously irradiated breast now being reconstructed (with or without contralateral mastectomy \& reconstruction)
* Patient utilized a textured expander only
* Patient utilized a smooth gel permanent implant only
* Patient has agreed and is able to comply with the study follow-up requirements
* Patient or guardian has provided consent for participation
Exclusion Criteria:
* Patient is undergoing single-stage breast reconstruction
* Patient is undergoing a delayed reconstruction
* Patient is undergoing reconstruction using a smooth tissue expander, textured gel breast implant or any saline breast implant.
* Patient is undergoing planned reconstruction using autologous tissue
* Patient has a known hypersensitivity to collagen or bovine derived materials
* Patient is currently pregnant, nursing, or planning a pregnancy during the course of the study
* Patient who has had pre-mastectomy XRT bilaterally for breast cancer (either at the same time or separated in time)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01959867
Study Brief:
Protocol Section:
NCT01959867