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 @ 2:41 PM
Ignite Modification Date:
2025-12-24 @ 2:41 PM
NCT ID:
NCT02167659
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed invasive breast cancer or Ductal Carcinoma In Situ (DCIS)
* Planned surgical procedure
* Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
* Prior history of breast cancer, breast/chest wall/axillary radiation therapy
* Definitive breast surgical procedure prior to enrollment.
* Active implanted medical device (e.g., cardiac pacemakers, defibrillators) or patients connected to electronic life support devices or metallic devices that would interfere with BIS measurements.
* Conditions that could cause swelling (e.g., pregnancy, congestive heart failure, chronic/acute renal disease, cor pulmonale, nephrotic syndrome, nephrosis, liver failure or cirrhosis, pulmonary edema, and thrombophlebitis, or deep vein thrombosis in arms
* Previous treatment for lymphedema of either arm.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris, or cardiac arrhythmia.
* Psychiatric illness (e.g., diagnosed schizophrenia or documented dementia) that would limit compliance with study requirements.
* Known allergy to electrode adhesives or woven knit compression fabrics
* Bilateral breast cancer or planned bilateral mastectomy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02167659
Study Brief:
Protocol Section:
NCT02167659