Evaluating a new surgical approach for upper arm lymphedema
Prospective Evaluation of Nanofibrillar Collagen Scaffold (BioBridge®) as an Adjunct to Lymph Node Transplant for Upper Extremity Lymphedema
This study is testing if adding a special collagen mesh to standard surgery can help people with upper arm lymphedema feel better and reduce swelling.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fibralign Corporation Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Stanford, California) |
| Trial ID | NCT05695924 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of adding Fibralign's BioBridge® Collagen Matrix to standard surgical procedures for vascularized lymph node transfer in patients with upper extremity lymphedema. The BioBridge is a biodegradable surgical mesh made from purified porcine collagen, designed to enhance surgical outcomes. The primary endpoint is the percentage change in excess limb volume measured 12 months post-surgery, while secondary endpoints include quality of life improvements and lymphatic function assessment using indocyanine green fluorescence imaging.
Who should consider this trial
Good fit: Ideal candidates are breast cancer survivors aged 18 to 75 with stage I-II lymphedema who have completed cancer therapy at least 3 years prior.
Not a fit: Patients who are not breast cancer survivors or those with lymphedema not related to breast cancer treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve surgical outcomes and quality of life for patients suffering from lymphedema.
How similar studies have performed: While the use of surgical interventions for lymphedema is established, the specific application of the BioBridge Collagen Matrix is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: The subject must be a breast cancer survivor, at least 3 years beyond completion of cancer therapy, free of clinical disease, and eligible for surgical intervention. Participants who are not able to safely undergo general anesthesia and/or perioperative care for VLNT are excluded. * Ages 18 to 75 years (inclusive) * Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2 * Life expectancy \> 2 years * Acquired (secondary) upper limb lymphedema secondary to breast cancer treatment * The participant must be eligible for surgical intervention * Swelling of 1 limb that is not completely reversed by elevation or compression * Stage I-II lymphedema at screening, based on the International Society of Lymphology (ISL) staging system * Participants must have no evidence of disease (NED), have completed breast cancer therapy 3 years prior to enrollment; use of endocrine therapy is allowed. * Completion of a full course of complete decongestive therapy (CDT), according to ISL guidelines at least 12 weeks prior to screening, including use of compression garments for at least 12 weeks without change in regimen * Willingness to comply with recommended regimen of self care, with consistent use of compression garments from screening through the entire study duration (through the safety follow up visit), excluding the first 3 weeks postoperatively where patients are required to not wear compression. Self bandaging, use of nighttime compression garments, and intermittent pneumatic compression devices are allowed, but the procedures and regimens are expected to remain consistent from screening though the entire study duration. * Consistent use of an appropriately sized compression garment for daytime use. * Limb volume (LV) in the affected limb and unaffected limb must be at least 10% of each other. * Evidence of abnormal bioimpedance ratio, if feasible, based upon unilateral disease: L Dex \> 10 units. * Willingness and ability to comply with all study procedures, including measurement of skin biopsy, and preoperative and postoperative imaging studies. * Willingness and ability to understand, and to sign a written informed consent form document Exclusion Criteria: * Edema arising from increased capillary filtration will be excluded (venous incompetence). * 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 (≤ 12 weeks) of CDPT for lymphedema * Other medical condition that could lead to acute limb edema, such as (but not limited to) acute venous thrombosis or heart failure * Other medical condition that could result in symptoms overlapping those of lymphedema in the affected limb (eg, pain, swelling, decreased range of motion) * History of clotting disorder (hypercoagulable state) * Chronic (persistent) infection in the affected limb * Infection of the lymphedema limb within 1 month prior to screening * Currently receiving chemotherapy or radiation therapy * Current evidence, or a history of malignancy within the past 3 years (except for non melanoma skin cancer or cervical cancer in situ treated with curative intent). If the participant has undergone cancer treatment, this must have been completed \> 3 years prior to enrollment. * 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 * Body Mass Index (BMI) \>35 * Known sensitivity to porcine products * Anaphylaxis to iodine * Pregnancy or nursing * Substance abuse (such as alcohol or drug abuse) within 6 months prior to screening * Any reason (in addition to those listed above) that, in the opinion of the investigator, precludes full participation in the study.
Where this trial is running
Stanford, California
- Stanford University — Stanford, California, United States (Recruiting)
Study contacts
- Study coordinator: Shannon Meyer
- Email: smeyer27@stanford.edu
- Phone: 650-721-1807
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.