Actively Recruiting
The Robot-LVA Study: Robot-assisted Microsurgical Lymphaticovenous Anastomosis in Breast Cancer-related Lymphedema
Led by Maastricht University Medical Center · Updated on 2024-08-01
60
Participants Needed
1
Research Sites
448 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Robot-LVA Study: Robot-assisted Microsurgical Lymphaticovenous Anastomosis in Breast Cancer-related Lymphedema
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female gender
- Treated for primary early stage breast cancer
- Early stage lymphedema of the arm (stage 1 or 2 on ISL classification)
- ELV > 10%
- Suffering from unilateral disease
You will not qualify if you...
- Male gender
- Stage 3 lymphedema of the arm
- Receiving current breast cancer treatment
- Distant breast cancer metastases
- Current substance abuse
- History of marcaine or indocyanine green allergy
- Non-viable lymphatic system as determined by near infrared imaging
- Previous LVA (<10 years) in the arm with lymphedema
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Maastricht University Medical Center+
Maastricht, Limburg, Netherlands, 6229HX
Actively Recruiting
Research Team
A
Alieske Kleeven, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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