Surgical Evaluation for Upper Extremity Lymphedema (BioBridge)

Launched by FIBRALIGN CORPORATION · Jan 13, 2023

Keywords

ClinConnect Summary

The BioBridge clinical trial is looking into whether a special collagen device called BioBridge can help improve the results of surgery for patients with lymphedema in the upper arm, particularly those who have had breast cancer. Lymphedema is a condition that causes swelling in the arm due to a buildup of lymph fluid, often after cancer treatment. This study is currently recruiting participants who are breast cancer survivors, at least 3 years past their treatment, and have certain types of arm swelling that don't go away with regular care like compression garments or elevation.

To participate, individuals must be between 18 and 75 years old, have completed a specific therapy for their lymphedema, and be eligible for surgery. They should also commit to following a care routine throughout the study. Participants will undergo surgery and will need to attend follow-up appointments to monitor their progress. This trial aims to explore if adding the BioBridge device during surgery can lead to better outcomes for patients dealing with lymphedema.

Gender

ALL

Eligibility 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.