RecruitingNot ApplicableNCT04606030

LymphBridge: Surgical Evaluation for Breast Cancer-Associated Lymphedema (BioBridge)

LymphBridge: Prospective Evaluation of the BioBridge Scaffold as an Adjunct to Lymph Node Transplant for Upper Extremity Lymphedema


Sponsor

Fibralign Corporation

Enrollment

60 participants

Start Date

Oct 26, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a surgical procedure to treat arm swelling (lymphedema) that developed after breast cancer treatment. Researchers want to see if transplanting lymph nodes from another part of the body into the affected arm can reduce swelling long-term. **You may be eligible if...** - You are a breast cancer survivor aged 18–75 - You finished all cancer treatment at least 3 years ago with no signs of cancer returning - You have persistent arm swelling (lymphedema) that doesn't go away with elevation or compression - You have completed a full course of physical therapy (decongestive therapy) for at least 12 weeks - You are healthy enough for surgery under general anesthesia - You have been consistently using compression garments **You may NOT be eligible if...** - You currently have active cancer or completed treatment less than 3 years ago - You cannot safely undergo surgery or general anesthesia - You have a blood clotting disorder or active infection in the arm - You are currently receiving chemotherapy or radiation - You are pregnant or breastfeeding - Your BMI is over 35 - You have significant kidney or liver problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEBioBridge® Collagen Matrix

BioBridge Collagen Matrix (BioBridge) is a sterile implantable bio-compatible and biodegradable surgical mesh ribbon comprised of highly purified porcine collagen. The Class II device was cleared by CDRH Division of Surgical Devices on 8 January 2016 under 510(k) K151083. The device will be used for soft tissue surgical support at the time of vascularized lymph node transplant surgery (VLNT); the device will be used, specifically, for surgical support of the lymphatic component of the soft tissue.

PROCEDUREVascularized Lymph Node Transfer (VLNT)

Micro-surgical procedure for vascularized lymph node transfer (VLNT)


Locations(2)

The University of Chicago Biological Sciences Division/University of Chicago Medical Center

Chicago, Illinois, United States

MD Anderson

Houston, Texas, United States

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NCT04606030


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