Clinical trial NCT04858230: LymphoPilot Test for Limb Lymphedema
Official title: Pilot Clinical Study to Assess Safety and Feasibility of a New Implantable Device in the Management of Limb Lymphedema
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lymphedema, Secondary
Lymphedema of Upper Limb
Lymphedema Arm
Lymphedema of Leg
Lymphedema, Lower Limb
Keywords: lymphedema
Lead sponsor: Lymphatica Medtech SA
Sponsor class: INDUSTRY
First posted: 2021-04-26
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Occurrence, frequency and severity of device-related adverse events
timeFrame: From enrollment until final visit, 4 weeks after device removal.
Secondary outcomes:
measure: Device functionality evaluated via ultrasound imaging
timeFrame: At day 1 (implant surgery), day 7, day 28 and day 56
measure: Limb volume
timeFrame: At day 0 (baseline), day 7, day 28, day 56, day 66, day 84
measure: L-Dex score
timeFrame: At day 0 (baseline), day 7, day 28, day 56, day 66, day 84
measure: Upper extremity function
timeFrame: At day 0 (baseline) and at day 56
measure: Lower extremity function
timeFrame: At day 0 (baseline) and at day 56
measure: Physical functioning evaluated via validated SF-36 questionnaire
timeFrame: At day 0 (baseline) and at day 56
measure: Role limitations due to physical health evaluated via validated SF-36 questionnaire
timeFrame: At day 0 (baseline) and at day 56
measure: Role limitations due to emotional problems evaluated via validated SF-36 questionnaire
timeFrame: At day 0 (baseline) and at day 56
measure: Energy/fatigue evaluated via validated SF-36 questionnaire
timeFrame: At day 0 (baseline) and at day 56
measure: Emotional well-being evaluated via validated SF-36 questionnaire
timeFrame: At day 0 (baseline) and at day 56
measure: Social functioning evaluated via validated SF-36 questionnaire
timeFrame: At day 0 (baseline) and at day 56
measure: Pain evaluated via validated SF-36 questionnaire
timeFrame: At day 0 (baseline) and at day 56
measure: General health evaluated via validated SF-36 questionnaire
timeFrame: At day 0 (baseline) and at day 56
measure: Quality of life evaluated via validated LYMQOL-leg questionnaire
timeFrame: At day 7 and at day 56
measure: Quality of life evaluated via validated LYMPH-ICF-UL questionnaire
timeFrame: At day 7 and at day 56
measure: Ease of use of the device
timeFrame: At day 7 and at day 56
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Angiology Service - Centre Hospitalier Universitaire Vaudois (CHUV)
state: Vaud
Study officials:
affiliation: CHUV
name: Lucia Mazzolai, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mazzolai L, Triacca V, Brochu-Vez MJ, Boucard V, Aberle M, Chaplet V, Ferrari V, Deglise S, Pisano M, Staubli S. Advancing women's health with a pioneering implant to treat breast cancer related lymphedema. Eur J Intern Med. 2025 May;135:64-73. doi: 10.1016/j.ejim.2025.01.027. Epub 2025 Feb 12.