Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06650592
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-14
Brief Title:
Objective Assessment of Outcomes Following Immediate Lymphatic Reconstruction LYMPHA
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Objective Assessment of Outcomes Following Immediate Lymphatic Reconstruction LYMPHA
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Immediate lymphatic reconstruction ILR is a novel surgical approach performed at the time of initial lymph node dissection with the goal of preventing lymphedema It involves the identification of lymphatic channels that are transected after lymph node dissection and microsurgical anastomosis of one or more lymphatic channel with a local recipient vein to re-direct upper extremity lymphatic drainage Although ILR carries significant promise in prevention of lymphedema there is a lack of high-level evidence supporting its efficacy because it is a novel surgical technique that is only offered at a few centers and not routinely covered by insurance carriers yet The University of Chicago Comprehensive Cancer Center UCCCC is one of the busiest microsurgery centers performing this procedure and as a Lymphedema Center of Excellence is in a unique position to investigate the efficacy of ILR in preventing lymphedema In addition the University has access to a world class microbiome research facility and colleagues There is no information on the skin microbiome of the axilla in patients undergoing treatment for breast cancer or those at risk for developing lymphedema Further exploratory studies such as this in a diverse patient population may lead to practice changing research in our approach to lymphedema management and prevention The purpose of this study is to determine the role of immediate lymphatic reconstruction and obtain objective data to correlate the existing self-reported rates of lymphedema at the University of Chicago
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None