Surgical Evaluation for Upper Extremity Lymphedema (BioBridge)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFibralign Corporation
About this trial
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.
Eligibility criteria
Qualifiers
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
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
Treatments tested in this trial
- BioBridge® Collagen Matrix
- Vascularized Lymph Node Transfer (VLNT)
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Fibralign Corporation
Lead sponsor
Stanford University
Collaborator
Source ClinicalTrials.gov