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 @ 7:45 PM
Ignite Modification Date:
2025-12-24 @ 7:45 PM
NCT ID:
NCT07127003
Eligibility Criteria:
Inclusion Criteria:
* Patients consenting for unilateral ALND \[prior history of sentinel lymph node biopsy (SLNBx) allowed if \<6 months from consent\]
* Patients consenting for unilateral SLNBx with possible ALND, with a clinically or radiographically positive lymph node OR a high likelihood of ALND per the Breast Surgeon
* Identification of at least one transected lymphatic channel and at least one vein to be used for bypass at the time of ALND during surgery
* Female breast cancer patients 18-75 years of age (inclusive)
Exclusion Criteria:
* • Male breast cancer patients
* Non-English speaking participants
* Female breast cancer patients with axillary recurrence
* Female breast cancer patients who have a history of ALND
* Female patients requiring bilateral ALND for the treatment of their breast cancer
* Female breast patients treated with SLNBx only
* Primary lymphedema of the affected upper limb
* Secondary lymphedema of the affected limb prior to the lymphadenectomy
* Radiotherapy at the axilla before the study / surgery
* Life expectancy \< 2 years for any reason
* Pregnancy or nursing
* Substance abuse (such as alcohol or drug abuse) within 6 months prior to screening
* Severe psychiatric disease
* Distant metastases at the time of preoperative screening
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07127003
Study Brief:
Protocol Section:
NCT07127003