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
Qualifiers
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
Treatments tested in this trial
- BioBridge
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov