Status:
TERMINATED
LymphoPilot Test for Limb Lymphedema
Lead Sponsor:
Lymphatica Medtech SA
Conditions:
Lymphedema, Secondary
Lymphedema of Upper Limb
Eligibility:
FEMALE
18+ years
Phase:
NA
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...
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...
Eligibility Criteria
Inclusion
- Female patients, 18 years and older
- Patients with unilateral secondary upper or lower limb lymphedema.
Exclusion
- 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
Key Trial Info
Start Date :
September 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2023
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04858230
Start Date
September 8 2021
End Date
September 30 2023
Last Update
March 7 2025
Active Locations (1)
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1
Angiology Service - Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, Switzerland, 1015