LymphBridge: Surgical Evaluation for Breast Cancer-Associated 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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
BioBridge® Collagen Matrix
DeviceBioBridge Collagen Matrix (BioBridge) is a sterile implantable bio-compatible and biodegradable surgical mesh ribbon comprised of highly purified porcine collagen. The Class II device was cleared by CDRH Division of Surgical Devices on 8 January 2016 under 510(k) K151083. The device will be used for soft tissue surgical support at the time of vascularized lymph node transplant surgery (VLNT); the device will be used, specifically, for surgical support of the lymphatic component of the soft tissue.
Vascularized Lymph Node Transfer (VLNT)
Procedure/SurgeryMicro-surgical procedure for vascularized lymph node transfer (VLNT)
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: BioBridge treatment groupExperimental treatment 2 interventions
Group B: Control groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Excess limb volume change
Change in % of (excess) limb volume in the intervention group relative to control group
Time frame
Baseline and 12 months after treatmentSecondary outcomes
1
LLIS survey
Lymphedema-specific instrument to measure impairments, activity limitations, and participation restrictions in those living with any extremity lymphedema
Time frame
Baseline and 12 months after treatment2
L-Dex bioimpedance spectroscopy.
Change in the Lymphedema Index (L-Dex) in the intervention group relative to control group. The L-Dex score has the requisite sensitivity and specificity to detect the differences in retained interstitial fluid that might discriminate the therapeutic responses of the treated patients. It has been established that the normal range of the L-Dex score is in the interval from -10 to +10 units; the higher score the more difference is in the retained interstitial fluid between the affected and unaffected limbs.
Time frame
Baseline and 12 months after treatment3
Histology
Change in cutaneous histological architecture. The impact of treatment on the cutaneous histopathology will be evaluated through the use of an empirically derived scoring system and will be performed by a dermatopathologist.
Time frame
Baseline and 12 months after treatment4
ICG fluorescence imaging
Change in lymphatic function assessed by ICG fluorescence imaging
Time frame
Baseline and 12 months after treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Fibralign Corporation
Lead sponsor
University of Chicago
Collaborator
Source ClinicalTrials.gov