← Back to Clinical Trials
Recruiting NCT06532955

The Robot-LVA Study: Robot-assisted Microsurgical Lymphaticovenous Anastomosis in Breast Cancer-related Lymphedema

Trial Parameters

Condition Lymphedema
Sponsor Maastricht University Medical Center
Study Type INTERVENTIONAL
Phase N/A
Enrollment 60
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2017-06-01
Completion 2026-01-01
Interventions
Lymphaticovenous anastomosis using Microsure Motion StabilizerLymphaticovenous anastomosis (manual)

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.

Eligibility Criteria

Inclusion Criteria: * 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 Criteria: * 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.

Related Trials