BioBridge for Swollen Arm
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether adding BioBridge, a medical device, to the usual surgery for lymphedema in the arm can improve treatment success. BioBridge aims to help transplanted lymph nodes connect better, potentially enhancing surgical effectiveness. Individuals with persistent swelling in one arm, despite elevation or compression, and who have already tried standard compression treatments, might be suitable for this trial. As an unphased trial, this study provides an opportunity to explore an innovative approach that could enhance surgical outcomes for lymphedema patients.
Do I need to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, you cannot participate if you are currently receiving chemotherapy or radiation therapy.
What prior data suggests that the BioBridge scaffold is safe for use in surgical treatment?
Research has shown that BioBridge is safe and effective for people with lymphedema. One study found that patients who used BioBridge with standard surgery experienced less swelling and grew new lymphatic vessels, with no reported complications. Another study discovered that patients managed swelling better over time when using BioBridge. These results suggest that BioBridge is safe for humans and helps improve lymphedema symptoms.12345
Why are researchers excited about this trial?
Researchers are excited about BioBridge for treating swollen arms, a condition often managed with vascularized lymph node transfer (VLNT), because it adds a new twist to the standard approach. Unlike the traditional method, BioBridge combines VLNT with a specialized scaffold that supports tissue regeneration. This innovative scaffold promotes lymphatic tissue growth, potentially enhancing the effectiveness of VLNT and offering better outcomes for patients. By fostering natural tissue repair, BioBridge could lead to more significant and quicker improvements in swelling reduction.
What evidence suggests that BioBridge is effective for improving surgical outcomes in lymphedema?
Research has shown that BioBridge can significantly aid in treating lymphedema, a condition characterized by swelling due to lymph fluid build-up. One study found that patients using BioBridge experienced a noticeable reduction in swelling over time. Another study observed that all patients saw a decrease in the size of the swollen area and even grew new lymphatic vessels, crucial for fluid drainage. In this trial, some participants will receive the standard vascularized lymph node transfer (VLNT), while others will receive VLNT with BioBridge. Previous studies revealed that patients who received both BioBridge and standard lymph node transfer achieved better long-term results, including reduced swelling. This suggests that BioBridge might enhance the success of current surgical treatments by improving connections to transplanted lymph nodes.13467
Are You a Good Fit for This Trial?
This trial is for individuals with Stage I-II upper limb lymphedema, who have a life expectancy over 2 years and are eligible for surgery. They must have completed decongestive therapy and be willing to wear compression garments consistently. Cancer survivors can join if they've been cancer-free for 3 years, but those with certain conditions that prevent wearing compression post-surgery cannot participate.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo vascularized lymph node transfer (VLNT) with or without the Biobridge scaffold
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BioBridge
Trial Overview
The study tests whether adding BioBridge scaffold to standard vascularized lymph node transfer surgery improves outcomes in treating arm lymphedema. It aims to see if BioBridge helps connect the transplanted nodes better, which could increase the success rate of this surgical treatment.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Standard of care vascularized lymph node transfer plus BioBridge placement
Standard of care vascularized lymph node transfer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor
Citations
Long-term results of lymphedema treatment with Combined ...
A long-term follow-up, has shown bigger volume reduction, decreasing the infection episodes per year and downstaging the lymphedema level in patients who ...
LymphBridge: Surgical Evaluation for Breast Cancer ...
The proposed study utilizes Fibralign's BioBridge® Collagen Matrix (BioBridge), a sterile implantable biocompatible and biodegradable surgical mesh ribbon ...
Biomaterials in the clinical treatment of lymphedema—a ...
ST implantation showed an average limb volume reduction of 700 to 887 mL and limb circumference reduction of 3.1 to 8 cm in patients with advanced stage ...
Lymphedema Surgical Treatment Using BioBridgeTM
All patients showed a significant reduction in the affected areas with the demonstration of new lymphatic vessels at MR imaging follow-up. This ...
BioBridge + VLNT for Lymphedema
Patients who received both BioBridge and VLNT experienced better long-term outcomes in managing lymphedema, such as reduced swelling. The collagen structure in ...
Biomaterials in the clinical treatment of lymphedema—a ...
No complications were 7documented after NCS implantation. ST implantation showed an average limb volume reduction of 700 to 887 mL and limb circumference ...
Surgical Evaluation for Upper Extremity Lymphedema ...
To investigate whether the addition of Fibralign's BioBridge® Collagen Matrix (BioBridge) devices to the standard surgery for vascularized lymph node ...
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