Prospective Evaluation of a Surgical Solution for Breast Cancer-Associated Lymphedema

Inclusion Criteria:

The subject must be a breast cancer survivor, at least three years beyond completion of cancer therapy, free of clinical disease, and eligible for surgical intervention.

Ages 18 to 75 years (inclusive).
Swelling of 1 limb that is not completely reversed by elevation or compression
Stage II or greater lymphedema at screening, based on the International Society of Lymphology (ISL) staging system
Completion of a full course of complete decongestive therapy (CDT), according to ISL guidelines at least 8 weeks prior to screening, including use of compression garments for at least 8 weeks without change in regimen
Willingness to maintain a stable regimen of self-care, with consistent use of compression garments from screening through the entire study duration (through the safety follow-up visit). Self-bandaging, use of nighttime compression garments, and intermittent pneumatic compression devices are allowed, but the procedures and regimens must remain consistent from screening though the entire study duration.
Two consecutive measurements of limb volume (LV) in the affected limb taken at least 1 day apart during the screening period must be within 10% of each other. A maximum of 3 measurements can be taken. Affected limb volume ratio >20% (affected limb compared to unaffected limb); volume measurements will be performed and volume ratio will be calculated at S1 and S2 visit.
Evidence of abnormal bioimpedance ratio, if feasible based upon unilateral disease: L-Dex >10 units; bioimpedance performed at S1 and S1
Willingness and ability to understand and the willingness to sign a written informed consent form document
Willingness and ability to comply with all study procedures, including measurement of skin thickness using skin calipers.
Participants must have NED, completed breast cancer therapy 3 years prior to enrollment.
ECOG 0- 2

Exclusion Criteria:

Edema arising from increased capillary filtration will be excluded.
Inability to safely undergo general anesthesia and/or perioperative care related to vascularized lymph node transfer
Concurrent participation in a clinical trial of any other investigational drug or therapy, regardless of indication, within 1 month before screening or 5 times the drug's half-life, whichever is longer
Recent initiation of (≤8 weeks), or intention to initiate, CDPT or maintenance physiotherapy for lymphedema at any time during the duration of the study
Other medical condition that could lead to acute limb edema, such as (but not limited to) 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)
History of clotting disorder (hypercoagulable state)
Chronic (persistent) infection in the affected limb
Any other infection (unrelated to lymphedema) within 1 month prior to screening
Current evidence of malignancy or any high risk for breast cancer recurrence (Stage III or IV, ER/PR/HER-2 negative (triple negative) cancer , locally advanced disease, inflammatory breast cancer, > 3 positive axillary lymph nodes, extracapsular nodal extension, invasive micropapillary breast carcinoma, or if performed, patients with a high risk of recurrence based on multi-gene signatures, e.g. BRCA1, BRCA 2, Oncotype DX (high risk recurrence score) or Mammaprint (poor risk signature)
Currently receiving chemotherapy or radiation therapy
Life expectancy < 2 years for any reason
Pregnancy or nursing
Substance abuse (such as alcohol or drug abuse) within 6 months prior to screening
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
Known sensitivity to porcine products
Any reason (in addition to those listed above) that, in the opinion of the investigator, precludes full participation in the study