Lymphedema, SecondaryNCT04858230
LymphoPilot Test for Limb Lymphedema
A study testing LymphoPilot in people with Lymphedema, Secondary and Lymphedema of Upper Limb, run by Lymphatica Medtech SA at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lymphedema, Secondary, Lymphedema of Upper Limb, Lymphedema Arm
- What is being tested?
- LymphoPilot
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- 8 Sep 2021to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients, 18 years and older
- Patients with unilateral secondary upper or lower limb lymphedema.
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Angiology Service - Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, 1015
About this study
Official title: Pilot Clinical Study to Assess Safety and Feasibility of a New Implantable Device in the Management of Limb Lymphedema
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.
Read the 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.
- Conditions
- Lymphedema, Secondary, Lymphedema of Upper Limb, Lymphedema Arm, Lymphedema of Leg, Lymphedema, Lower Limb
- Being tested
- LymphoPilot
- Keywords
- lymphedema
- Medical subject headings
- Lymphedema, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LymphoPilotDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: LymphoPilot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence, frequency and severity of device-related adverse events
Occurrence, frequency and severity of device-related adverse events are used to evaluate device safety
Measured: From enrollment until final visit, 4 weeks after device removal.
Secondary outcomes (16)
Device functionality evaluated via ultrasound imaging
Ultrasound imaging is used to verify fluid flow in the implanted catheters
Measured: At day 1 (implant surgery), day 7, day 28 and day 56
Limb volume
Arm or leg volume evaluated by tape measure and by perometer
Measured: At day 0 (baseline), day 7, day 28, day 56, day 66, day 84
L-Dex score
L-Dex score is measured via bioimpedance spectroscopy
Measured: At day 0 (baseline), day 7, day 28, day 56, day 66, day 84
Upper extremity function
The Quick Disability of Arm, Shoulder, Hand Questionnaire (DASH) is used to evaluate upper extremity function
Measured: At day 0 (baseline) and at day 56
Lower extremity function
The Lower Extremity Functional Scale (LEFS) is used to evaluate lower extremity function
Measured: At day 0 (baseline) and at day 56
Physical functioning evaluated via validated SF-36 questionnaire
The Short Form-36 (SF-36) questionnaire is used to evaluate patient's physical functioning.
Scoring scale: 0 to 100%, where the highest percentage represents the best outcome.
Measured: At day 0 (baseline) and at day 56
Role limitations due to physical health evaluated via validated SF-36 questionnaire
The Short Form-36 (SF-36) questionnaire is used to evaluate patient's role limitations due to physical health.
Scoring scale: 0 to 100%, where the highest percentage represents the best outcome.
Measured: At day 0 (baseline) and at day 56
Role limitations due to emotional problems evaluated via validated SF-36 questionnaire
The Short Form-36 (SF-36) questionnaire is used to evaluate patient's role limitations due to emotional problems.
Scoring scale: 0 to 100%, where the highest percentage represents the best outcome.
Measured: At day 0 (baseline) and at day 56
Energy/fatigue evaluated via validated SF-36 questionnaire
The Short Form-36 (SF-36) questionnaire is used to evaluate patient's energy/fatigue.
Scoring scale: 0 to 100%, where the highest percentage represents the best outcome.
Measured: At day 0 (baseline) and at day 56
Emotional well-being evaluated via validated SF-36 questionnaire
The Short Form-36 (SF-36) questionnaire is used to evaluate patient's emotional well-being.
Scoring scale: 0 to 100%, where the highest percentage represents the best outcome.
Measured: At day 0 (baseline) and at day 56
Social functioning evaluated via validated SF-36 questionnaire
The Short Form-36 (SF-36) questionnaire is used to evaluate patient's social functioning.
Scoring scale: 0 to 100%, where the highest percentage represents the best outcome.
Measured: At day 0 (baseline) and at day 56
Pain evaluated via validated SF-36 questionnaire
The Short Form-36 (SF-36) questionnaire is used to evaluate patient's pain. Scoring scale: 0 to 100%, where the highest percentage represents the best outcome.
Measured: At day 0 (baseline) and at day 56
General health evaluated via validated SF-36 questionnaire
The Short Form-36 (SF-36) questionnaire is used to evaluate patient's general health.
Scoring scale: 0 to 100%, where the highest percentage represents the best outcome.
Measured: At day 0 (baseline) and at day 56
Quality of life evaluated via validated LYMQOL-leg questionnaire
The Lymphedema Quality of Life Questionnaire for leg Lymphedema (LYMQOL-LEG) questionnaire is used to evaluate assessing problems in functioning in patients with lower limb lymphedema.
Scoring scale: 0-10, where highest scores represent the best outcome.
Measured: At day 7 and at day 56
Quality of life evaluated via validated LYMPH-ICF-UL questionnaire
The Lymphedema Functioning, Disability and Health Questionnaire for Upper Limb Lymphedema (LYMPH-ICF-UL) questionnaire is used to evaluate assessing problems in functioning in patients with upper limb lymphedema.
Scoring scale: 0-100, where highest scores mean a worse outcome.
Measured: At day 7 and at day 56
Ease of use of the device
Device usability evaluated via dedicated survey
Measured: At day 7 and at day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start8 Sep 2021
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Why it stopped: End of shelf life of investigational devices.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lymphedema, SecondaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lymphatica Medtech SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lucia Mazzolai, Prof., Principal investigator, CHUV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04858230
- Sponsor's protocol ID
- LymphoPilot
- Status last verified
- Mar 2025
- First submitted
- 13 Apr 2021
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39939264
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Clinical Study to Assess Safety and Feasibility of a New Implantable Device in the Management of Limb Lymphedema
- ClinicalTrials.gov ID
- NCT04858230
- Acronym / sponsor ID
- LymphoPilot
- Conditions
- Lymphedema, Secondary, Lymphedema of Upper Limb, Lymphedema Arm, Lymphedema of Leg, Lymphedema, Lower Limb
- Keywords
- lymphedema
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: End of shelf life of investigational devices.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Lymphatica Medtech SAIndustry (pharma, biotech, devices)
- Study start
- 8 Sep 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 26 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LymphoPilot | Experimental | Device: LymphoPilotPatient 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Female patients, 18 years and older
- Patients with unilateral secondary upper or lower limb lymphedema.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LymphoPilotLymphoPilot 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. | Device | LymphoPilot |
Primary outcome
Occurrence, frequency and severity of device-related adverse events
Time frame: From enrollment until final visit, 4 weeks after device removal.
Occurrence, frequency and severity of device-related adverse events are used to evaluate device safety
16 secondary outcomes
Device functionality evaluated via ultrasound imaging
Time frame: At day 1 (implant surgery), day 7, day 28 and day 56
Limb volume
Time frame: At day 0 (baseline), day 7, day 28, day 56, day 66, day 84
L-Dex score
Time frame: At day 0 (baseline), day 7, day 28, day 56, day 66, day 84
Upper extremity function
Time frame: At day 0 (baseline) and at day 56
Lower extremity function
Time frame: At day 0 (baseline) and at day 56
Physical functioning evaluated via validated SF-36 questionnaire
Time frame: At day 0 (baseline) and at day 56
Role limitations due to physical health evaluated via validated SF-36 questionnaire
Time frame: At day 0 (baseline) and at day 56
Role limitations due to emotional problems evaluated via validated SF-36 questionnaire
Time frame: At day 0 (baseline) and at day 56
Energy/fatigue evaluated via validated SF-36 questionnaire
Time frame: At day 0 (baseline) and at day 56
Emotional well-being evaluated via validated SF-36 questionnaire
Time frame: At day 0 (baseline) and at day 56
Social functioning evaluated via validated SF-36 questionnaire
Time frame: At day 0 (baseline) and at day 56
Pain evaluated via validated SF-36 questionnaire
Time frame: At day 0 (baseline) and at day 56
General health evaluated via validated SF-36 questionnaire
Time frame: At day 0 (baseline) and at day 56
Quality of life evaluated via validated LYMQOL-leg questionnaire
Time frame: At day 7 and at day 56
Quality of life evaluated via validated LYMPH-ICF-UL questionnaire
Time frame: At day 7 and at day 56
Ease of use of the device
Time frame: At day 7 and at day 56
Results and safety
The study was stopped early (reason given: End of shelf life of investigational devices.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Results publication: PubMed 39939264Mazzolai 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucia Mazzolai, Prof. principal investigator
CHUV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LymphoPilot in people with Lymphedema, Secondary and Lymphedema of Upper Limb, run by Lymphatica Medtech SA at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: End of shelf life of investigational devices.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence, frequency and severity of device-related adverse events (time frame: From enrollment until final visit, 4 weeks after device removal.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04858230, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.