Health Trials

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

ConditionsLymphedemaLymphedema ArmLymphedema of Upper ArmLymphedema of Upper LimbLymphedema; SurgicalLymphedema, SecondaryLymphedema of LimbLymphedema, Breast CancerLymphedema, Non-Filarial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMaastricht University Medical Center

About this trial

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

Qualifiers

Female gender;

Treated for primary early stage breast cancer;

Early stage lymphedema of the arm (stage 1 or 2 on ISL classification);

ELV > 10%;

Disqualifiers

Male gender;

Stage 3 lymphedema of the arm;

Receiving current breast cancer treatment;

Distant breast cancer metastases;

Trial design

Treatments tested in this trial

  • Lymphaticovenous anastomosis using Microsure Motion Stabilizer
  • Lymphaticovenous anastomosis (manual)

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Maastricht University Medical Center

Lead sponsor

Source ClinicalTrials.gov