Surgical Evaluation for Upper Extremity Lymphedema (BioBridge)

NCT05695924 | Recruiting DMC FDA Device

• 1 other identifier: IRB-67367
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lymphedema; Edema

Keywords

Lymphedema; Edema

Outcome Measures

Primary Outcomes (1)

• Excess limb volume change

  Change in % of (excess) limb volume in the intervention group relative to control group

  Baseline and 12 months after treatment

Secondary Outcomes (4)

• LLIS survey

  Baseline and 12 months after treatment

• L-Dex bioimpedance spectroscopy.

  Baseline and 12 months after treatment

• Histology

  Baseline and 12 months after treatment

• ICG fluorescence imaging

  Baseline and 12 months after treatment

Study Arms (2)

BioBridge treatment group

EXPERIMENTAL

Vascularized Lymph Node Transplant surgery (VLNT) supplemented by BioBridge Collagen Matrix implantation

Device: BioBridge® Collagen Matrix; Procedure: Vascularized Lymph Node Transfer (VLNT)

Control group

ACTIVE COMPARATOR

Vascularized Lymph Node Transplant surgery (VLNT) only

Procedure: Vascularized Lymph Node Transfer (VLNT)

Interventions

BioBridge® Collagen Matrix DEVICE

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.

BioBridge treatment group

Vascularized Lymph Node Transfer (VLNT) PROCEDURE

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

BioBridge treatment group; Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 surgical intervention. Participants who are not able to safely undergo general anesthesia and/or perioperative care for VLNT are excluded.
• 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.

You may not qualify 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 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

Sponsors & Collaborators

• Fibralign Corporation: lead
• Stanford University: collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

RECRUITING

Related Publications (8)

• 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.

  PMID: 27556764 BACKGROUND

• 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.

  PMID: 26846735 BACKGROUND

• 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.

  PMID: 31209884 BACKGROUND

• 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.

  PMID: 31228351 BACKGROUND

• 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.

  PMID: 30562150 BACKGROUND

• 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.

  PMID: 34705812 BACKGROUND

• 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.

  PMID: 35160049 BACKGROUND

• 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.

  PMID: 34549427 BACKGROUND

MeSH Terms

Conditions

Lymphedema; Edema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dung H Nguyen, MD, PharmD

  Stanford University

  STUDY DIRECTOR

Central Study Contacts

Shannon Meyer

CONTACT

650-721-1807; smeyer27@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Partially Blinded: Patients will be informed which group they are randomized into and given the option to opt out of the study. Investigators (other than surgeons conducting surgery) and study personnel involved in patient measurements will be unaware of the patient treatment option.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, control arm

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: January 25, 2023
• Study Start: November 1, 2023
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)