Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06532955
NA

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

Sponsor: Maastricht University Medical Center

View on ClinicalTrials.gov

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.

Official title: Pilot Study on Robotic Assisted Microsurgical Lymphatico-venular Anastomosis

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2017-06-01

Completion Date

2026-01-01

Last Updated

2024-08-01

Healthy Volunteers

No

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

Locations (1)

Maastricht University Medical Center+

Maastricht, Limburg, Netherlands