LymphoPilot Test for Limb Lymphedema

Lymphatica Medtech SA12 enrolled

Overview

The present study is a first-in-man, single arm, open-label, single center study to assess feasibility and safety of a novel implantable device, LymphoPilot, in patients suffering from secondary upper limb or lower lymphedema.

The study consists in a first-in-man clinical investigation for LymphoPilot, an investigational implantable medical device. LymphoPilot is composed of an implanted part and an external wearable device. The implanted part (pump, drainage catheter and output catheter), is implanted in the subcutaneous tissue of the arm or leg and drains excess fluids to the supraclavicular or abdominal subcutaneous tissue, where fluids are naturally reabsorbed by the healthy lymphatic and venous system. The external part consists in a wearable controller used to activate the implanted pump. 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. The device is activated in the postoperative room by placing the external wearable device on patient's limb, in proximity of the implanted pump. Patients are required to wear the external controller continuously throughout the study, except 30 minutes per day, to allow taking a shower/bath. Follow-up visits are planned 1, 4 and 8 weeks after device implantation. The implanted device is removed with a surgical procedure in local anesthesia 8 weeks after device implantation, and 2 additional follow-up visits are planned after device removal.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Lymphedema, Secondary Lymphedema of Upper Limb Lymphedema Arm Lymphedema of Leg Lymphedema, Lower Limb

Interventions

LymphoPilotDEVICE

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Female patients, 18 years and older * Patients with unilateral secondary upper or lower limb lymphedema. Exclusion Criteria: * Active cellulitis/infection * Lymphedema associated with active cancer requiring chemotherapy or radiotherapy * Motor and sensitive neurological deficiency * Post-operative edema (i.e. acute edema following breast cancer related surgery) * Any contraindication to surgery or to loco-regional or general anesthesia * Patient participating in any other clinical study * Patient unable to provide informed consent * Patient with pacemaker * Pathologies associated with an overload of the cardiac system * Poor wound healing * Pregnancy or breastfeeding * Known intolerance to implantable devices * Known allergies to silicone * Patient needing magnetic therapy * Any other condition that according to the principal investigator makes the patient unsuitable for the participation in the trial * Patient refusing to receive information about incidental findings on her health status discovered during the clinical investigation * L-Dex score lower than 6.5 at screening

Locations (1)

Angiology Service - Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, Switzerland

Outcomes

Primary Outcomes

Occurrence, frequency and severity of device-related adverse events

Occurrence, frequency and severity of device-related adverse events are used to evaluate device safety

Time frame: From enrollment until final visit, 4 weeks after device removal.

Secondary Outcomes

Device functionality evaluated via ultrasound imaging

Ultrasound imaging is used to verify fluid flow in the implanted catheters

Time frame: At day 1 (implant surgery), day 7, day 28 and day 56

Limb volume

Arm or leg volume evaluated by tape measure and by perometer

Time frame: At day 0 (baseline), day 7, day 28, day 56, day 66, day 84

L-Dex score

L-Dex score is measured via bioimpedance spectroscopy

Time frame: At day 0 (baseline), day 7, day 28, day 56, day 66, day 84

Upper extremity function

The Quick Disability of Arm, Shoulder, Hand Questionnaire (DASH) is used to evaluate upper extremity function

Time frame: At day 0 (baseline) and at day 56

Lower extremity function

The Lower Extremity Functional Scale (LEFS) is used to evaluate lower extremity function

Time frame: At day 0 (baseline) and at day 56

Physical functioning evaluated via validated SF-36 questionnaire

The Short Form-36 (SF-36) questionnaire is used to evaluate patient's physical functioning. Scoring scale: 0 to 100%, where the highest percentage represents the best outcome.

Data from ClinicalTrials.gov

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