Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06532955
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
The Robot-LVA Study Robot-assisted Microsurgical Lymphaticovenous Anastomosis in Breast Cancer-related Lymphedema
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pilot Study on Robotic Assisted Microsurgical Lymphatico-venular Anastomosis
Status:
RECRUITING
Status Verified Date:
2024-07
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:
This study assesses the performance of robot-assisted microsurgery Lymphaticovenous anastomosis LVA is the most difficult procedure in microsurgery at this moment The LVA technique is applied to treat for example breast cancer-related lymphedema BCRL Therefore this LVA procedure is compared using a manual expert and the same expert applying robot-assisted LVA
Detailed Description:
Microsurgery facilitates procedures such as transplantation of tissue as well as lymphedema treatment Currently the plastic surgeons hands are the limiting factor in microsurgical performance Robot-assistence increases the movement in precision and might therefore be of great importance for the advancement of microsurgery in the world
It is a prospective study in Maastricht University Medical Center assessing 60 patients undergoing either robot-assisted or manual lymphaticovenous anastomosis LVA tot treat breast cancer-related lymphedema BCRL The primary outcome parameter is LVA technique Secondary outcome measures include duration of surgery technical errors during complications peri-operatively surgeons satisfaction with the LVA procedure teh patients convenience during surgery arm volume over time and patients symptoms development over time
It is a prospective study in Maastricht University Medical Center assessing 60 patients undergoing either robot-assisted or manual lymphaticovenous anastomosis LVA tot treat breast cancer-related lymphedema BCRL The primary outcome parameter is LVA technique Secondary outcome measures include duration of surgery technical errors during complications peri-operatively surgeons satisfaction with the LVA procedure teh patients convenience during surgery arm volume over time and patients symptoms development over time
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