LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy
Eligible age
18–75 yrs
Accepts
Women
Locations
1 state
Healthy volunteers
No
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About this study
Lymphedema is a chronic, progressive, and debilitating condition that occurs with disruption or obstruction of the lymphatic system, which commonly occurs a result of breast cancer therapy. The purpose of this study is to determine if the use of a low risk lymphatic reconstruction procedure at the time of axillary lymph node dissection will reduce the risk of developing lymphedema. Additionally, to determine if this procedure improves objective outcomes of lymphedema and patient quality of life
Sponsor: Stanford University
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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)
Where it's recruiting
San Francisco
Source: ClinicalTrials.gov · NCT05366699 · last updated 2026-08-12