Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Secondary lymphedema is the most common cause of lymphedema in the western world. Vascularized lymph node transfer (VLNT) is currently practiced with increasing frequency in the human disease population. This study will determined the efficacy of the Biobridge when used with VLNT in the human subjects with lymphedema; efficacy in large animal models has already been demonstrated. Patients with lymphedema who had BioBridge placed for soft tissue reinforcement after scar release has been observed to have improved lymph drainage and improvement of their limb volume.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VLNT | Active Comparator | Standard of care vascularized lymph node transfer |
|
| VLNT with Biobridge | Experimental | Standard of care vascularized lymph node transfer plus BioBridge placement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BioBridge | Device | Fibralign 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
| 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. | 12 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dung Nguyen, MD, PharmD | Contact | (650) 725-2766 | nguyendh@stanford.edu | |
| Elizabeth Tadevosyan, BS | Contact | 818-269-1950 | etadyan@stanford.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Hospital and Clinics | Recruiting | Palo Alto | California | 94304 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
VLNT or VLNT with BioBridge placement
Not provided
Not provided
patients will be blinded and be randomized via a blocked randomization design. Approximately 60 patients will be randomized in a 4:1 ratio to the intervention arm (VLNT + BioBridge): control arm (VLNT alone). Randomization will be done within blocks (of size 5) so that the balance between treatments is preserved throughout the trial.
|