Stanford, CANCT05695924Now EnrollingIRB Ready

Lymphedema Clinical Trial in Stanford, CA

Access cutting-edge lymphedema treatment through this clinical trial at a research site in Stanford. Study-provided care at no cost to qualified participants.

Sponsored by Fibralign Corporation

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Expert Care in Stanford

Access lymphedema specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related lymphedema treatment provided free

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Check if you qualify for this lymphedema clinical trial in Stanford, CA

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Why Participate?

  • No-Cost Study Care

  • Local to Stanford

    Convenient for CA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Stanford site if eligible
  4. 4Begin participation

About This Lymphedema Study in Stanford

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.

Sponsor: Fibralign Corporation

Who Can Participate

Inclusion Criteria

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.
Willingness and ability to understand, and to sign a written informed consent form document

Exclusion Criteria

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
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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Stanford?

Yes, this clinical trial (NCT05695924) has an active research site in Stanford, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Lymphedema Treatment Options in Stanford, CA

If you're searching for lymphedema treatment options in Stanford, CA, this clinical trial (NCT05695924) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Stanford research site is actively enrolling participants for this clinical trial. You'll receive care from experienced lymphedema specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all lymphedema clinical trials near you to find additional studies recruiting in your area.

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