- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05825157
Prospective Evaluation of Combination Therapy for Upper Extremity Lymphedema
April 20, 2023 updated by: Dung Nguyen, Stanford University
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.
Study Overview
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 Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
- 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
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 (e.g., 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
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: VLNT
Standard of care vascularized lymph node transfer
|
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.
|
Experimental: VLNT with Biobridge
Standard of care vascularized lymph node transfer plus BioBridge placement
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 months
|
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.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
June 1, 2023
Primary Completion (Anticipated)
January 1, 2026
Study Completion (Anticipated)
January 1, 2028
Study Registration Dates
First Submitted
November 29, 2022
First Submitted That Met QC Criteria
April 20, 2023
First Posted (Actual)
April 24, 2023
Study Record Updates
Last Update Posted (Actual)
April 24, 2023
Last Update Submitted That Met QC Criteria
April 20, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 67367
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lymphedema Arm
-
Carilion ClinicVirginia Polytechnic Institute and State UniversityNot yet recruitingLymphedema | Lymphedema of Upper Arm | Lymphedema ArmUnited States
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Swansea Bay University Health BoardSwansea University; Huntleigh Healthcare Ltd; Lymphoedema Wales Clinical NetworkCompleted
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Mayo ClinicActive, not recruitingLymphedema ArmUnited States
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Assiut UniversityWithdrawnLymphedema | Lymphedema of Upper Arm | Mastectomy; Lymphedema
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ThuasneInternational Clinical Trials AssociationRecruitingLymphedema of Upper ArmFrance, Turkey
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Stanford UniversityCelltaxis LLCRecruitingLymphedema of Upper ArmUnited States
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Massachusetts General HospitalHeinz Family FoundationRecruitingBreast Cancer | Lymphedema | Edema | Lymphedema of Upper Arm | Breast Cancer Lymphedema | Breast Cancer Metastatic | Lymphedema of Upper Limb | Breast Cancer Stage | Lymphedema Arm | Edema Arm | Lymphedema of the HandsUnited States
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Lymphatica Medtech SATerminatedLymphedema of Upper Limb | Lymphedema, Secondary | Lymphedema, Lower Limb | Lymphedema of Leg | Lymphedema ArmSwitzerland
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Universitaire Ziekenhuizen KU LeuvenRecruitingLymphedema | Lymphedema Arm | Lymphoedema of LegBelgium
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Maastricht University Medical CenterRadboud University Medical Center; Erasmus Medical CenterRecruitingLymphedema of Upper Limb | Lymphedema, Secondary | Lymphedema, Lower Limb | Lymphedema of Leg | Lymphedema ArmNetherlands
Clinical Trials on BioBridge
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Fibralign CorporationStanford UniversityRecruiting
-
Fibralign CorporationUniversity of ChicagoRecruitingLymphedema | EdemaUnited States
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Stanford UniversityCompletedLymphedema | EdemaUnited States