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

NARecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

June 1, 2017

Primary Completion Date

January 1, 2026

Study Completion Date

January 1, 2026

Conditions
LymphedemaLymphedema ArmLymphedema of Upper ArmLymphedema of Upper LimbLymphedema; SurgicalLymphedema, SecondaryLymphedema of LimbLymphedema, Breast CancerLymphedema, Non-Filarial
Interventions
DEVICE

Lymphaticovenous 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."

PROCEDURE

Lymphaticovenous 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

Trial Locations (1)

6229HX

RECRUITING

Maastricht University Medical Center+, Maastricht

All Listed Sponsors
lead

Maastricht University Medical Center

OTHER