Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04606030
Status:
RECRUITING
Last Update Posted:
2023-06-01
First Post:
2020-10-25
Brief Title:
LymphBridge Surgical Evaluation for Breast Cancer-Associated Lymphedema BioBridge
Sponsor:
Fibralign Corporation
Organization:
Fibralign Corporation
Study Overview
Official Title:
LymphBridge Prospective Evaluation of the BioBridge Scaffold as an Adjunct to Lymph Node Transplant for Upper Extremity Lymphedema
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To investigate whether the addition of Fibraligns 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 Fibraligns 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 510k 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None