LymphoPilot Test for Limb Lymphedema

NATerminatedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

September 8, 2021

Primary Completion Date

September 30, 2023

Study Completion Date

September 30, 2023

Conditions
Lymphedema, SecondaryLymphedema of Upper LimbLymphedema ArmLymphedema of LegLymphedema, Lower Limb
Interventions
DEVICE

LymphoPilot

"LymphoPilot is an investigational medical device composed of an implanted part (pump, drainage catheter and output catheter), implanted in the subcutaneous tissue of the arm or of the leg and draining excess fluids to the supraclavicular or abdominal subcutaneous tissue, where fluids are naturally reabsorbed by the healthy lymphatic and venous system. The implanted part is activated and controlled via a wearable device.~The subcutaneous implantation of the device is performed in loco-regional or general anesthesia, in ambulatorial settings, and the patient is dismissed from the hospital on the same day of the procedure.~Patients will wear the external controller continuously throughout the study, except 30 minutes per day, to allow taking a shower/bath. The implanted device will be removed with a surgical procedure in local anesthesia 8 weeks after device implantation."

Trial Locations (1)

1015

Angiology Service - Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne

Sponsors
All Listed Sponsors
lead

Lymphatica Medtech SA

INDUSTRY