Ignite Creation Date:
2024-05-06 @ 6:53 PM
Last Modification Date:
2025-12-16 @ 5:57 PM
Study NCT ID:
NCT05825157
Status:
None
Last Update Posted:
2023-04-24 00:00:00
First Post:
2022-11-29 00:00:00
Brief Title:
Prospective Evaluation of Combination Therapy for Upper Extremity Lymphedema
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Prospective Evaluation of Combination Therapy for Upper Extremity Lymphedema
Status:
None
Status Verified Date:
2023-04
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:
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.
Detailed Description:
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
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