Clinical trial · Interventional
LymphoPilot Test for Limb Lymphedema
Pilot Clinical Study to Assess Safety and Feasibility of a New Implantable Device in the Management of Limb Lymphedema
NCT04858230CI-TRIAL-00086902terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): End of shelf life of investigational devices.
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphedema Arm | — | UNRESOLVED | — |
| Lymphedema, Lower Limb | — | UNRESOLVED | — |
| Lymphedema of Leg | — | UNRESOLVED | — |
| Lymphedema of Upper Limb | — | UNRESOLVED | — |
| Lymphedema, Secondary | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LymphoPilot | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LymphoPilot
- description
- 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.
- interventionNames
- Device: LymphoPilot
Primary outcomes (1)
- measure
- Occurrence, frequency and severity of device-related adverse events
- timeFrame
- From enrollment until final visit, 4 weeks after device removal.
- description
- Occurrence, frequency and severity of device-related adverse events are used to evaluate device safety
Secondary outcomes (16)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTMazzolai 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