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 @ 3:09 AM
Ignite Modification Date:
2025-12-25 @ 3:09 AM
NCT ID:
NCT02161705
Eligibility Criteria:
Inclusion Criteria:
* Be Female aged 18-100 years.
* Choose mastectomy followed by bilateral immediate tissue expander breast reconstruction.
* Have no inflammatory breast cancers.
* Be aware of the nature of her malignancy.
* Understand the study purpose, requirements, and risks.
* Be able and willing to give informed consent.
Exclusion Criteria:
* Any concurrent opioid analgesic use (baseline opioid use must be 0 to be eligible).
* Liver dysfunction and/ or cirrhosis.
* Renal insufficiency, with creatinine greater than 1.5 mg/mL.
* Patients weighing less than 50 Kg.
* Concurrent use of the SSRI antidepressant fluvoxamine (Luvox).
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02161705
Study Brief:
Protocol Section:
NCT02161705