LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy

Inclusion Criteria:

   - Ages 18 to 75 years (inclusive)

   - Patients undergoing unilateral or bilateral breast cancer related axillary
   lymphadenectomy

   - Free of distant metastasis in preoperative screening

   - Histology results of axillary lymph nodes could be either Negative or Positive

   - Patients who undergo preoperative chemotherapy can be included

   - Willingness and ability to provide written informed consent

   - Willingness and ability to comply with all study procedures

Exclusion Criteria:

   - 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

   - Allergic reaction to porcine collagen or ICG

   - Receiving radiation therapy to the involved nodal basin in a period less than 4 weeks
   after the surgery

   - Concurrent participation in a clinical trial of any other investigational drug or
   therapy, regardless of indication, within 1 month before screening

   - Other medical condition that could lead to limb edema, such as (but not limited to
   primary lymphedema or acute venous thrombosis

   - Other medical condition that could result in symptoms overlapping those of lymphedema
   in the affected limb (e.g., pain, swelling, decreased range of motion)

   - Either of the following, at the time of baseline evaluation: ipsilateral:contralateral
   limb volume ratio>1.1 or R0 bioimpedance ratio > 1.106 when the nondominant limb is at
   risk, and 1.134 when the dominant limb is at risk.

   - 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

   - Significant or chronic renal insufficiency (defined as serum creatinine > 2.5 mg/dL or
   an estimated glomerular filtration rate [eGFR] < 30 mL/min at screening) or requires
   dialytic support

   - Hepatic dysfunction, defined as alanine transaminase (ALT) or aspartate transaminase
   (AST) levels > 3 × upper limit of the normal range (ULN) and/or bilirubin level > 2 ×
   ULN at screening

   - Absolute neutrophil count < 1500 mm3 at screening

   - Hemoglobin concentration < 9 g/dL at screening

   - Any reason (in addition to those listed above) that, in the opinion of the
   investigator, precludes full participation in the study