LymphoPilot Test for Limb Lymphedema

NCT04858230 | Terminated DMC

• 1 other identifier: LymphoPilot
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

lymphedema

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Device functionality evaluated via ultrasound imaging

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

• Limb volume

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

• L-Dex score

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

• Upper extremity function

  At day 0 (baseline) and at day 56

• Lower extremity function

  At day 0 (baseline) and at day 56

Study Arms (1)

LymphoPilot

EXPERIMENTAL

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

Interventions

LymphoPilot DEVICE

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.

LymphoPilot

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients, 18 years and older
• Patients with unilateral secondary upper or lower limb lymphedema.

You may not qualify if:

• 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

Sponsors & Collaborators

• Lymphatica Medtech SA: lead

Study Sites (1)

Angiology Service - Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, 1015, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 39939264 BACKGROUND

MeSH Terms

Conditions

Lymphedema; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lucia Mazzolai, Prof.

  CHUV

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 26, 2021
• Study Start: September 8, 2021
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)