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 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT03667560
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of breast cancer
* Candidate for and decide to undergo implant-based reconstruction
* Willing and able to provided written informed consent and comply with the study protocol.
Exclusion Criteria:
* Women planning to undergo radiation treatment or whose tumor characteristics of the mastectomy specimen dictate that post-op radiation will be required.
* Women planning to undergo adjuvant chemotherapy.
* Women who have had prior breast cancer treated with breast conservation therapy requiring radiation for the same breast being treated will be excluded.
* Known sensitivity to either of the following antibiotics: lincomycin, gentamicin, polymyxin B, or vancomycin.
* Women who have the presence of any condition that in the opinion of the investigator places the participant at undue risk or potentially jepordizes the quality of data to be generated.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03667560
Study Brief:
Protocol Section:
NCT03667560