LymphoPilot Test for Limb Lymphedema

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pilot Clinical Study to Assess Safety and Feasibility of a New Implantable Device in the Management of Limb Lymphedema

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

Intervention / Treatment
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* Device: LymphoPilot


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LymphoPilot<br>Patient will be implanted with the medical device under investigation, LymphoPilot, through a surgical procedure performed in loco-regional or general anesthesia. Lymphedema outcomes will be monitored for 8 weeks after implantation and compared to baseline values before device implantation. Safety data will be collected throughout the study. | Device: LymphoPilot<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence, frequency and severity of device-related adverse events | Occurrence, frequency and severity of device-related adverse events are used to evaluate device safety | From enrollment until final visit, 4 weeks after device removal. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device functionality evaluated via ultrasound imaging | Ultrasound imaging is used to verify fluid flow in the implanted catheters | 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 | 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 | 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 | At day 0 (baseline) and at day 56 | 
| Lower extremity function | The Lower Extremity Functional Scale (LEFS) is used to evaluate lower extremity function | 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. | At day 0 (baseline) and at day 56 | 
| Role limitations due to physical health evaluated via validated SF-36 questionnaire | The Short Form-36 (SF-36) questionnaire is used to evaluate patient's role limitations due to physical health. Scoring scale: 0 to 100%, where the highest percentage represents the best outcome. | At day 0 (baseline) and at day 56 | 
| Role limitations due to emotional problems evaluated via validated SF-36 questionnaire | The Short Form-36 (SF-36) questionnaire is used to evaluate patient's role limitations due to emotional problems. Scoring scale: 0 to 100%, where the highest percentage represents the best outcome. | At day 0 (baseline) and at day 56 | 
| Energy/fatigue evaluated via validated SF-36 questionnaire | The Short Form-36 (SF-36) questionnaire is used to evaluate patient's energy/fatigue. Scoring scale: 0 to 100%, where the highest percentage represents the best outcome. | At day 0 (baseline) and at day 56 | 
| Emotional well-being evaluated via validated SF-36 questionnaire | The Short Form-36 (SF-36) questionnaire is used to evaluate patient's emotional well-being. Scoring scale: 0 to 100%, where the highest percentage represents the best outcome. | At day 0 (baseline) and at day 56 | 
| Social functioning evaluated via validated SF-36 questionnaire | The Short Form-36 (SF-36) questionnaire is used to evaluate patient's social functioning. Scoring scale: 0 to 100%, where the highest percentage represents the best outcome. | At day 0 (baseline) and at day 56 | 
| Pain evaluated via validated SF-36 questionnaire | The Short Form-36 (SF-36) questionnaire is used to evaluate patient's pain. Scoring scale: 0 to 100%, where the highest percentage represents the best outcome. | At day 0 (baseline) and at day 56 | 
| General health evaluated via validated SF-36 questionnaire | The Short Form-36 (SF-36) questionnaire is used to evaluate patient's general health. Scoring scale: 0 to 100%, where the highest percentage represents the best outcome. | At day 0 (baseline) and at day 56 | 
| Quality of life evaluated via validated LYMQOL-leg questionnaire | The Lymphedema Quality of Life Questionnaire for leg Lymphedema (LYMQOL-LEG) questionnaire is used to evaluate assessing problems in functioning in patients with lower limb lymphedema. Scoring scale: 0-10, where highest scores represent the best outcome. | At day 7 and at day 56 | 
| Quality of life evaluated via validated LYMPH-ICF-UL questionnaire | The Lymphedema Functioning, Disability and Health Questionnaire for Upper Limb Lymphedema (LYMPH-ICF-UL) questionnaire is used to evaluate assessing problems in functioning in patients with upper limb lymphedema. Scoring scale: 0-100, where highest scores mean a worse outcome. | At day 7 and at day 56 | 
| Ease of use of the device | Device usability evaluated via dedicated survey | At day 7 and at day 56 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lymphedema