Lymphedema ArmNCT05825157
Evaluation of Combination Therapy for Upper Extremity Lymphedema
A study testing BioBridge in people with Lymphedema Arm, run by Stanford University at 1 site in United States.
Trial summary
Investigate whether the addition of the Biobridge scaffold to the standard surgery for vascularized lymph node transfer will improve the outcome of surgical treatment in lymphedema of the upper extremity. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Lymphedema Arm
- What is being tested?
- BioBridge
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2023to 1 Jan 2029
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18 to 75 years (inclusive)
- Life expectancy > 2 years
- Upper limb lymphedema
- 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
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- Participants with a history of cancer 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 limb volume, 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 (e.g., 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
- 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.
United States1 site, 1 recruiting
- Recruiting
Stanford Hospital and Clinics
Palo Alto, California, 94304
Dung Nguyen, MD PharmD, (650) 725-2766, nguyendh@stanford.edu
Elizabeth Tadevosyan, BS, 818-269-1950, etadyan@stanford.edu
About this study
Official title: Prospective Evaluation of Combination Therapy for Upper Extremity Lymphedema
Investigate whether the addition of the Biobridge scaffold to the standard surgery for vascularized lymph node transfer will improve the outcome of surgical treatment in lymphedema of the upper extremity. Will Biobridge improve upon the low success rate of the currently practiced surgery by facilitating the lymphatic connections to the transplanted node that are crucial to its viability and function.
Read the detailed description
Secondary lymphedema is the most common cause of lymphedema in the western world. Vascularized lymph node transfer (VLNT) is currently practiced with increasing frequency in the human disease population. This study will determined the efficacy of the Biobridge when used with VLNT in the human subjects with lymphedema; efficacy in large animal models has already been demonstrated. Patients with lymphedema who had BioBridge placed for soft tissue reinforcement after scar release has been observed to have improved lymph drainage and improvement of their limb volume.
- Conditions
- Lymphedema Arm
- Being tested
- BioBridge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioBridgeDevice
Fibralign BioBridge is a thread-like, multi-lumen scaffold consisting of highly aligned collagen fibrils, optimized to encourage the endothelial cell attachment,alignment and migration that are prerequisites to new vessel formation. BioBridge is a device made from highly purified, medical-grade porcine collagen.
| Study group | Role | What they receive |
|---|---|---|
| VLNT | Active comparator | Standard of care vascularized lymph node transfer Receives: Device: BioBridge |
| VLNT with Biobridge | Experimental | Standard of care vascularized lymph node transfer plus BioBridge placement Receives: Device: BioBridge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improve the outcome of surgical treatment of upper extremity lymphedema
To measure the post-surgical percent change in excess limb volume measured at 12 months following surgery using BioBridge scaffold as an adjunct to vascularized lymph node transfer for treatment of upper extremity lymphedema
Measured: 12 months
Improve the outcome of surgical treatment of upper extremity lymphedema
Primary endpoint is % change in (excess) limb volume, from baseline to Month 12, in the intervention group relative to control group. Dispersion (variance) will be assessed as the standard deviation.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start17 Nov 2023
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphedema ArmStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- VLNT or VLNT with BioBridge placement
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dung Nguyen, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05825157
- Sponsor's protocol ID
- 67367
- Status last verified
- Dec 2025
- First submitted
- 29 Nov 2022
- Last updated
- 24 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Combination Therapy for Upper Extremity Lymphedema
- ClinicalTrials.gov ID
- NCT05825157
- Acronym / sponsor ID
- 67367
- Conditions
- Lymphedema Arm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 17 Nov 2023 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 24 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigate whether the addition of the Biobridge scaffold to the standard surgery for vascularized lymph node transfer will improve the outcome of surgical treatment in lymphedema of the upper extremity. Will Biobridge improve upon the low success rate of the currently practiced surgery by facilitating the lymphatic connections to the transplanted node that are crucial to its viability and function.
Detailed description
Secondary lymphedema is the most common cause of lymphedema in the western world. Vascularized lymph node transfer (VLNT) is currently practiced with increasing frequency in the human disease population. This study will determined the efficacy of the Biobridge when used with VLNT in the human subjects with lymphedema; efficacy in large animal models has already been demonstrated. Patients with lymphedema who had BioBridge placed for soft tissue reinforcement after scar release has been observed to have improved lymph drainage and improvement of their limb volume.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- VLNT or VLNT with BioBridge placement
| Arm | Type | Receives |
|---|---|---|
| VLNT | Active comparator | Device: BioBridgeStandard of care vascularized lymph node transfer |
| VLNT with Biobridge | Experimental | Device: BioBridgeStandard of care vascularized lymph node transfer plus BioBridge placement |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Ages 18 to 75 years (inclusive)
- Life expectancy > 2 years
- Upper limb lymphedema
- The participant must be eligible for surgical intervention
- Swelling of 1 limb that is not completely reversed by elevation or compression
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioBridgeFibralign BioBridge is a thread-like, multi-lumen scaffold consisting of highly aligned collagen fibrils, optimized to encourage the endothelial cell attachment,alignment and migration that are prerequisites to new vessel formation. BioBridge is a device made from highly purified, medical-grade porcine collagen. | Device | VLNT, VLNT with Biobridge |
Primary outcome
Improve the outcome of surgical treatment of upper extremity lymphedema
Time frame: 12 months
To measure the post-surgical percent change in excess limb volume measured at 12 months following surgery using BioBridge scaffold as an adjunct to vascularized lymph node transfer for treatment of upper extremity lymphedema
Improve the outcome of surgical treatment of upper extremity lymphedema
Time frame: 12 months
Primary endpoint is % change in (excess) limb volume, from baseline to Month 12, in the intervention group relative to control group. Dispersion (variance) will be assessed as the standard deviation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BioBridge in people with Lymphedema Arm, run by Stanford University 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 14 inclusion and 16 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 24 Dec 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 Dung Nguyen, MD, PharmD ((650) 725-2766, nguyendh@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improve the outcome of surgical treatment of upper extremity lymphedema (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.