RecruitingNot ApplicableNCT06532955

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

Pilot Study on Robotic Assisted Microsurgical Lymphatico-venular Anastomosis


Sponsor

Maastricht University Medical Center

Enrollment

60 participants

Start Date

Jun 1, 2017

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether robot-assisted microsurgery can better treat arm swelling (lymphedema) that develops after breast cancer treatment. Lymphedema happens when the lymphatic drainage system is damaged during cancer surgery or radiation. A procedure called lymphaticovenous anastomosis (LVA) creates tiny connections between lymphatic vessels and veins to restore drainage — and this study tests a robotic-assisted version to see if it offers better precision than conventional microsurgery. **You may be eligible if...** - You are a woman who has been treated for early-stage breast cancer - You have early-stage lymphedema of the arm (ISL stage 1 or 2 — meaning there is swelling that may or may not resolve with elevation) - Your affected arm is more than 10% larger than the other arm - Only one arm is affected **You may NOT be eligible if...** - You are male - Your lymphedema is stage 3 (severe, with hardened tissue) - You are currently receiving breast cancer treatment - Your breast cancer has spread to distant parts of the body - You have had a previous LVA procedure in the last 10 years - You have an allergy to indocyanine green (a dye used in imaging) - Your lymphatic system is no longer viable on imaging Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICELymphaticovenous anastomosis using Microsure Motion Stabilizer

The robot-assisted LVA is performed using the Microsure Motion Stabilizer, a telemanipulation tool that stabilizes a surgeon's movement during open microsurgical operations on extremities, specifically on veins and nerves that are close to the skin. The surgeon controls a joystick, which directly copies the surgeon's movements in real-time to an instrument held by the device. The device's software scales down the motions and filters out tremor. Surgical technique and method of treatment are identical to conventional microsurgery. The device is equipped with genuine microsurgical instruments and is compatible with existing surgical microscopes. Instead of holding the instrument directly in hand, which is limited in precision and dexterity, the surgeon operates while the instrument's movements are stabilized. The modular design allows the surgeon to decide what level of manipulation assistance is required during a certain procedure.

PROCEDURELymphaticovenous anastomosis (manual)

Lymphaticovenous anastomosis (LVA) involves connecting a lymphatic vessel to an adjacent vein of similar size, thereby facilitating the outflow of lymphatic fluid in patients suffering from secondary lymphedema


Locations(1)

Maastricht University Medical Center+

Maastricht, Limburg, Netherlands

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NCT06532955


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