Evaluation of Combination Therapy for Upper Extremity Lymphedema
ConditionLymphedema Arm
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorStanford University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ages 18 to 75 years (inclusive)
Life expectancy > 2 years
Upper limb lymphedema
The participant must be eligible for surgical intervention
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
BioBridge
DeviceFibralign 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: VLNTActive comparator 1 intervention
Group B: VLNT with BiobridgeExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
12 months2
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.
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov