Status:
RECRUITING
The Robot-LVA Study: Robot-assisted Microsurgical Lymphaticovenous Anastomosis in Breast Cancer-related Lymphedema
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Lymphedema
Lymphedema Arm
Eligibility:
FEMALE
18+ years
Phase:
NA
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 t...
Detailed Description
Microsurgery facilitates procedures such as transplantation of tissue as well as lymphedema treatment. Currently, the plastic surgeon's hands are the limiting factor in microsurgical performance. Robo...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06532955
Start Date
June 1 2017
End Date
January 1 2026
Last Update
August 1 2024
Active Locations (1)
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1
Maastricht University Medical Center+
Maastricht, Limburg, Netherlands, 6229HX