LymphoPilot Test for Limb Lymphedema (NCT04858230) | Clinical Trial Compass
TerminatedNot Applicable
LymphoPilot Test for Limb Lymphedema
Stopped: End of shelf life of investigational devices.
Switzerland12 participantsStarted 2021-09-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Occurrence, frequency and severity of device-related adverse events
Timeframe: From enrollment until final visit, 4 weeks after device removal.