BioBridge + VLNT for Lymphedema
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Fibralign Corporation
Must not be taking: Chemotherapy, Radiation therapy
Disqualifiers: Heart failure, Clotting disorder, others
No Placebo Group
Approved in 4 jurisdictions
Trial Summary
What is the purpose of this trial?This trial is testing if adding BioBridge, a biodegradable mesh made from pig collagen, to standard surgery can help patients with upper arm lymphedema. The mesh supports new lymph nodes to improve fluid drainage and reduce swelling. BioBlanket Surgical Mesh, a collagen-based surgical mesh, has been evaluated for its potential to facilitate soft tissue repair in an animal model.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are currently receiving chemotherapy or radiation therapy, you cannot participate in the trial.
What data supports the effectiveness of the treatment BioBridge + VLNT for Lymphedema?
The research highlights the importance of reliable monitoring and successful outcomes in procedures involving vascularized tissue transfer, like VLNT, which is part of the BioBridge + VLNT treatment. Although not directly related to lymphedema, the studies suggest that vascularized transfers are effective in complex reconstructions, indicating potential benefits for lymphedema treatment.
12345Is the BioBridge + VLNT treatment generally safe for humans?
Vascularized lymph node transfer (VLNT) is a surgical treatment for lymphedema that is gaining popularity, but it is associated with a risk of causing lymphedema in other areas (iatrogenic lymphedema). Efforts are being made to minimize complications, such as using specific techniques to reduce risks at the donor site.
678910How is the treatment Vascularized Lymph Node Transfer (VLNT) unique for lymphedema?
Vascularized Lymph Node Transfer (VLNT) is a surgical treatment that involves transferring healthy lymph nodes to the affected area to help reduce swelling and improve lymphatic drainage. Unlike other treatments, VLNT is a relatively novel technique that can provide long-term relief by restoring the lymphatic system, although it may take time to show effects.
79111213Eligibility Criteria
This trial is for breast cancer survivors aged 18-75 with Stage I-II upper limb lymphedema after treatment, who've completed a full course of decongestive therapy. Participants must be free of cancer for 3 years, have no severe organ dysfunction or clotting disorders, not be pregnant or nursing, and able to undergo surgery.Inclusion Criteria
I finished my breast cancer treatment 3 years ago and currently have no signs of the disease.
Life expectancy > 2 years
Limb volume (LV) in the affected limb and unaffected limb must be at least 10% of each other
+12 more
Exclusion Criteria
I have swelling due to fluid leakage from blood vessels.
I have not had an infection in my swollen limb in the last month.
I have a long-lasting infection in my limb.
+17 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Surgical Treatment
Participants undergo vascularized lymph node transplant surgery, with or without BioBridge Collagen Matrix implantation
1 week
1 visit (in-person)
Follow-up
Participants are monitored for changes in excess limb volume, quality of life, lymphatic function, and histological architecture
12 months
Regular visits (in-person) over 12 months
Participant Groups
The study tests if adding BioBridge® Collagen Matrix to standard vascularized lymph node transfer surgery improves outcomes in treating arm swelling due to lymphedema in breast cancer survivors.
2Treatment groups
Experimental Treatment
Active Control
Group I: BioBridge treatment groupExperimental Treatment2 Interventions
Vascularized Lymph Node Transplant surgery (VLNT) supplemented by BioBridge Collagen Matrix implantation
Group II: Control groupActive Control1 Intervention
Vascularized Lymph Node Transplant surgery (VLNT) only
Vascularized Lymph Node Transfer (VLNT) is already approved in United States, European Union, Canada, Japan for the following indications:
🇺🇸 Approved in United States as Vascularized Lymph Node Transfer for:
- Upper extremity lymphedema
- Lower extremity lymphedema
🇪🇺 Approved in European Union as Vascularized Lymph Node Transfer for:
- Upper extremity lymphedema
- Lower extremity lymphedema
- Breast cancer-related lymphedema
🇨🇦 Approved in Canada as Vascularized Lymph Node Transfer for:
- Upper extremity lymphedema
- Lower extremity lymphedema
🇯🇵 Approved in Japan as Vascularized Lymph Node Transfer for:
- Upper extremity lymphedema
- Lower extremity lymphedema
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Stanford UniversityStanford, CA
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Who Is Running the Clinical Trial?
Fibralign CorporationLead Sponsor
Stanford UniversityCollaborator
References
Implantable Doppler monitoring of buried free flaps during vascularized lymph node transfer. [2017]Reliable flap monitoring is crucial to the success of free tissue transfer, including vascularized lymph node transfer (VLNT). However, no large-scale study has examined implantable Doppler monitoring in VLNT. We aimed to determine whether an implantable Doppler system can reliably monitor flap perfusion during VLNT and also to calculate the sensitivity and specificity of this system for detecting compromise in the monitored vessel.
Massive bone defects of the upper limb: reconstruction by vascularized bone transfer. [2007]Vascularized bone transfer is increasingly recognized as a very useful and versatile technique for reconstructing massive bone defects in the upper limb or in patients with especially challenging conditions, such as infected nonunions and nonunions associated with radionecrosis of bone. It is especially indicated for the humerus and shoulder region with more selected applications in the forearm or wrist. Although technically challenging, the outcomes of this procedure justify consideration along with alternative methods for major reconstructions of the upper limb.
Vascularized bone segment transfers for management of chronic osteomyelitis. [2004]Vascularized bone segment transfer procedures appear to be of value for select cases of chronic osteomyelitis. They are particularly indicated for reconstruction in those patients who require an extensive bone resection for an adequate debridement. In the authors' series, apparent control of sepsis was achieved in approximately 85 per cent of patients with this procedure. Secondary surgical procedures were necessary in about half of the group to achieve bony union and complete healing.
[Vascularloops in reconstructive microsurgery: A review of the literature]. [2022]The success of free tissue transfer depends on the quality of vascular micro-anastomosis and recipient vessels. Adequate recipient vessels are sometimes not available near the recipient site for they can be either destroyed or of poor quality (radiotherapy, traumatism). In such cases, good quality recipient vessels are at a distance from the reconstructed site. If this distance is important flap pedicle lengthening implies - for the artery, for the vein or for both flap artery and vein. This lengthening can be carried out in two manners - by interpositional vein grafts (VG) or by a vascular loop (VL) in one or two stages. The aim of this study was to review the utilisation of VL and their type since their introduction in the clinical practice of reconstructive microsurgery. Two main types of VL are used - BV by VG and VL "in situ". Both of them can be carried out in one or two stages. Each of these techniques has its advantages and disadvantages. The overall data from the literature shows that VL are indicated in cases where both artery and vein are damaged or destroyed. There is not enough evidence concerning the VL in one or two stages but there are some tendencies in favour of the VL in one stage. The technique of VL seems to be more avantageous over the interpositional VG but with a smaller success rate compared to free-flaps with direct anastomosis to recipient vessels. Further studies are necessary to investigate these controversial questions.
[Free vascularized bone transplantation]. [2016]A report is presented on 4 years of experience with free vascularized bone transplants for extremity preservation and the postoperative management developed in this connection. The successful results so far were achieved not least by virtue of a strict unified postoperative treatment scheme extending from direct postoperative blood-flow monitoring through the raising of a skin flap and angiographic control of anastomosis patency to immobilization/mobilization and orthotic management. Thus far, 33 patients have been treated with free vascularized bone transplants (20 fibula, 13 iliac crest grafts).
Quantification of level I neck lymph nodes for lymph node transfer in lymphedema treatment: an anatomical study and review of literature. [2023]Vascularized lymph node transfer (VLNT) is an effective microsurgical method for the treatment of lymphedema. Knowledge of lymph node quantity and regional anatomy of donor sites are essential for surgery optimization. The aim of the study was to quantify the level I lymph nodes of the neck (submental and submandibular lymph nodes), describe the regional anatomy and review the current literature.
Efficacy validation of a lymphatic drainage device for lymphedema drainage in a rat model. [2020]Vascularized lymph node transfer (VLNT) is an effective surgery for extremity lymphedema. This study evaluated a lymphatic drainage device (LDD) for the drainage of accumulated fluid into the venous system.
Intra-abdominal vascularized lymph node transfer for treatment of lymphedema: A systematic literature review and meta-analysis. [2021]As a promising treatment for lymphedema, vascularized lymph node transfer (VLNT) is associated with a risk of iatrogenic lymphedema. Intra-abdominal vascularized lymph node flap has been increasingly applied to minimize complication.
Vascularized gastroepiploic lymph node transfer significantly improves breast cancer-related lymphedema. [2020]Vascularized lymph node transfer (VLNT) is a surgical treatment for lymphedema. Multiple methods have been described and each has significant disadvantages.
The use of supraclavicular free flap with vascularized lymph node transfer for treatment of lymphedema: A prospective study of 100 consecutive cases. [2022]Vascularized lymph node transfer (VLNT) is gaining popularity for treatment of lymphedema. The purpose of this study was to evaluate the flap and the donor site morbidity of the supraclavicular (SC) VLNT.
Preliminary outcomes of combined surgical approach for lower extremity lymphedema: supraclavicular lymph node transfer and lymphaticovenular anastomosis. [2022]Vascularized lymph node transfer (VLNT) is a well-established surgical approach for treating lower extremity lymphedema (LEL). Since VLNT takes time to show effect, a combined approach with lymphaticovenular anastomosis (LVA) may be more advantageous to patients by inducing an immediate improvement. This study aims to describe our experience and evaluate the results of a combined approach.
Free vascularized lymph node transfer for treatment of lymphedema: A systematic evidence based review. [2019]Free vascularized lymph node transfer (VLNT) is a relatively novel technique for treatment of lymphedema. The purpose of this systematic review was to evaluate the current evidence on VLNT and to determine if there is objective data concerning improved outcomes.
A systematic review and meta-analysis of vascularized lymph node transfer for breast cancer-related lymphedema. [2022]Vascularized lymph node transfer (VLNT) has become an increasingly popular technique for treating lymphedema. However, although many studies have been performed, its efficacy in increasing patients' quality of life (QoL) and reducing lymphedema in the affected body part has remained controversial. In the present systematic review, we summarized the evidence for VLNT for treating breast cancer-related lymphedema.