LymphBridge: Prospective Evaluation of the BioBridge Scaffold as an Adjunct to Lymph Node Transplant for Upper Extremity Lymphedema
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lymphedema
- Sponsor
- Fibralign Corporation
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Excess limb volume change
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
The proposed study utilizes Fibralign's BioBridge® Collagen Matrix (BioBridge), a sterile implantable biocompatible 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. Primary endpoint is the post surgical % change in excess limb volume, measured at 12 months following the surgical procedure. Secondary endpoints are change in quality of life scores measured by LLIS and change in lymphatic function as measured by indocyanine green (ICG) fluorescence imaging.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The subject must be a breast cancer survivor, at least 3 years beyond completion of cancer therapy, free of clinical disease, and eligible for surgical intervention. Participants who are not able to safely undergo general anesthesia and/or perioperative care for VLNT are excluded.
- •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
- •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 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
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 (eg, 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
Outcomes
Primary Outcomes
Excess limb volume change
Time Frame: Baseline and 12 months after treatment
Change in % of (excess) limb volume in the intervention group relative to control group
Secondary Outcomes
- LLIS survey(Baseline and 12 months after treatment)
- Histology(Baseline and 12 months after treatment)
- L-Dex bioimpedance spectroscopy.(Baseline and 12 months after treatment)
- ICG fluorescence imaging(Baseline and 12 months after treatment)