Surgical Evaluation for Upper Extremity Lymphedema (BioBridge)
NCT ID: NCT05695924
Last Updated: 2025-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
60 participants
INTERVENTIONAL
2023-11-01
2025-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Collagen Scaffold for the Repair of Elbow Cartilage Injury
NCT07149896
PMCF Study on the Safety, Performance and Clinical Benefits Data of the ToggleLoc™ 2.9mm in the Elbow
NCT05519228
Autologous Chondrocyte Implantation in the Patellofemoral Joint
NCT00212849
Zimmer Biomet Shoulder Arthroplasty PMCF
NCT04984291
Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Knee Osteoarthritis
NCT06608134
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The study will investigate whether addition of the BioBridge Collagen Matrix to the standard surgery for vascularized lymph node transfer will improve the outcome of surgical treatment in lymphedema of the upper extremity. This clinical study will also be used in support of IDE G200200 review conducted by the FDA.
Primary endpoint is the post surgical % change in excess limb volume, measured at 12 months following the surgical procedure.
Secondary endpoints are change in quality of life scores measured by LLIS and change in lymphatic function as measured by indocyanine green (ICG) fluorescence imaging.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
BioBridge treatment group
Vascularized Lymph Node Transplant surgery (VLNT) supplemented by BioBridge Collagen Matrix implantation
BioBridge® 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.
Vascularized Lymph Node Transfer (VLNT)
Micro-surgical procedure for vascularized lymph node transfer (VLNT)
Control group
Vascularized Lymph Node Transplant surgery (VLNT) only
Vascularized Lymph Node Transfer (VLNT)
Micro-surgical procedure for vascularized lymph node transfer (VLNT)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BioBridge® 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.
Vascularized Lymph Node Transfer (VLNT)
Micro-surgical procedure for vascularized lymph node transfer (VLNT)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Stanford University
OTHER
Fibralign Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Dung H Nguyen, MD, PharmD
Role: STUDY_DIRECTOR
Stanford University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Stanford University
Stanford, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Dung H Nguyen, MD, PharmD
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Chang DW, Masia J, Garza R 3rd, Skoracki R, Neligan PC. Lymphedema: Surgical and Medical Therapy. Plast Reconstr Surg. 2016 Sep;138(3 Suppl):209S-218S. doi: 10.1097/PRS.0000000000002683.
Silva AK, Chang DW. Vascularized lymph node transfer and lymphovenous bypass: Novel treatment strategies for symptomatic lymphedema. J Surg Oncol. 2016 Jun;113(8):932-9. doi: 10.1002/jso.24171. Epub 2016 Feb 5.
Rochlin DH, Inchauste S, Zelones J, Nguyen DH. The role of adjunct nanofibrillar collagen scaffold implantation in the surgical management of secondary lymphedema: Review of the literature and summary of initial pilot studies. J Surg Oncol. 2020 Jan;121(1):121-128. doi: 10.1002/jso.25576. Epub 2019 Jun 18.
Inchauste S, Zelones J, Rochlin D, Nguyen DH. Successful treatment of lymphedema in a vasculopath and neuropathic patient. J Surg Oncol. 2020 Jan;121(1):182-186. doi: 10.1002/jso.25590. Epub 2019 Jun 22.
Garza RM, Ooi ASH, Falk J, Chang DW. The Relationship Between Clinical and Indocyanine Green Staging in Lymphedema. Lymphat Res Biol. 2019 Jun;17(3):329-333. doi: 10.1089/lrb.2018.0014. Epub 2018 Dec 18.
Nguyen DH, Zhou A, Posternak V, Rochlin DH. Nanofibrillar Collagen Scaffold Enhances Edema Reduction and Formation of New Lymphatic Collectors after Lymphedema Surgery. Plast Reconstr Surg. 2021 Dec 1;148(6):1382-1393. doi: 10.1097/PRS.0000000000008590.
Deptula P, Zhou A, Posternak V, He H, Nguyen D. Multimodality Approach to Lymphedema Surgery Achieves and Maintains Normal Limb Volumes: A Treatment Algorithm to Optimize Outcomes. J Clin Med. 2022 Jan 25;11(3):598. doi: 10.3390/jcm11030598.
Nguyen D, Zaitseva TS, Zhou A, Rochlin D, Sue G, Deptula P, Tabada P, Wan D, Loening A, Paukshto M, Dionyssiou D. Lymphatic regeneration after implantation of aligned nanofibrillar collagen scaffolds: Preliminary preclinical and clinical results. J Surg Oncol. 2022 Feb;125(2):113-122. doi: 10.1002/jso.26679. Epub 2021 Sep 21.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB-67367
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.