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LymphedemaNCT05695924

Surgical Evaluation for Upper Extremity Lymphedema (BioBridge)

A study testing BioBridge® Collagen Matrix and Vascularized Lymph Node Transfer (VLNT) in people with Lymphedema and Edema, run by Fibralign Corporation at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Lymphedema, Edema
What is being tested?
BioBridge® Collagen Matrix and Vascularized Lymph Node Transfer (VLNT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
1 Nov 2023to 1 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 16Show fewer
  • 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

Who cannot join

  • 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)
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Shannon Meyer contact

650-721-1807

smeyer27@stanford.edu

United States1 site, 1 recruiting

  • Stanford University

    Stanford, California, 94305

    Dung H Nguyen, MD, PharmD

    Recruiting

Other trials in United States

About this study

Official title: Prospective Evaluation of Nanofibrillar Collagen Scaffold (BioBridge®) as an Adjunct to Lymph Node Transplant 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 transfer will improve the outcome of surgical treatment in lymphedema of the upper arm.

Read the detailed description

The proposed study utilizes Fibralign's BioBridge® Collagen Matrix (BioBridge), a sterile implantable biocompatible 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 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
Lymphedema, Edema
Being tested
BioBridge® Collagen Matrix, Vascularized Lymph Node Transfer (VLNT)
Keywords
Lymphedema, Edema
Medical subject headings
Lymphedema, Edema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BioBridge® Collagen MatrixDevice

    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)Procedure or surgery

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

Study groups in NCT05695924
Study groupRoleWhat they receive
BioBridge treatment groupExperimentalVascularized Lymph Node Transplant surgery (VLNT) supplemented by BioBridge Collagen Matrix implantation
Receives: Device: BioBridge® Collagen Matrix; Procedure: Vascularized Lymph Node Transfer (VLNT)
Control groupActive comparatorVascularized Lymph Node Transplant surgery (VLNT) only
Receives: Procedure: Vascularized Lymph Node Transfer (VLNT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Excess limb volume change

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

    Measured: Baseline and 12 months after treatment

Secondary outcomes (4)

  1. LLIS survey

    Lymphedema-specific instrument to measure impairments, activity limitations, and participation restrictions in those living with any extremity lymphedema

    Measured: Baseline and 12 months after treatment

  2. L-Dex bioimpedance spectroscopy.

    Change in the Lymphedema Index (L-Dex) in the intervention group relative to control group. The L-Dex score has the requisite sensitivity and specificity to detect the differences in retained interstitial fluid that might discriminate the therapeutic responses of the treated patients. It has been established that the normal range of the L-Dex score is in the interval from -10 to +10 units; the higher score the more difference is in the retained interstitial fluid between the affected and unaffected limbs.

    Measured: Baseline and 12 months after treatment

  3. Histology

    Change in cutaneous histological architecture. The impact of treatment on the cutaneous histopathology will be evaluated through the use of an empirically derived scoring system and will be performed by a dermatopathologist.

    Measured: Baseline and 12 months after treatment

  4. ICG fluorescence imaging

    Change in lymphatic function assessed by ICG fluorescence imaging

    Measured: Baseline and 12 months after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2023
  2. Study start1 Nov 2023
  3. Primary completion1 Oct 2025 (estimated)
  4. Study completion1 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, randomized, control arm
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05695924
Sponsor's protocol ID
IRB-67367
Status last verified
Mar 2025
First submitted
13 Jan 2023
Last updated
11 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 27556764

  • 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.

    PubMed 26846735

  • 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.

    PubMed 31209884

  • 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.

    PubMed 31228351

  • 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.

    PubMed 30562150

  • 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.

    PubMed 34705812

  • 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.

    PubMed 35160049

  • 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.

    PubMed 34549427

Questions about this trial

What is this clinical trial studying?

A study testing BioBridge® Collagen Matrix and Vascularized Lymph Node Transfer (VLNT) in people with Lymphedema and Edema, run by Fibralign Corporation at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Shannon Meyer (650-721-1807, smeyer27@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Excess limb volume change (time frame: Baseline and 12 months after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05695924, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.

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