BridgeMD
New treatment option for Lymphedema
Official title LymphBridge: Surgical Evaluation for Breast Cancer-Associated Lymphedema (BioBridge)
ClinicalTrials.gov ID: NCT04606030
What this study is testing
- What it's testing
- To investigate whether the addition of Fibralign's BioBridge® Collagen Matrix (BioBridge) devices to the standard surgery for vascularized lymph node transfer will improve the outcome of surgical treatment in lymphedema of the upper arm.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- The subject must be a breast cancer survivor, at least 3 years beyond completion of cancer therapy, free of clinical disease, and eligible for...
- 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
You likely can't join if
- 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...
- 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...
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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
What rules you out
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.