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New device aims to ease leg swelling in lymphedema patients

NCT ID NCT07603531

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests if a new dynamic compression device, used with compression stockings, works as well as current treatments for reducing leg swelling in people with lymphedema. About 98 adults with stage II or III lymphedema will use either the new device or standard wraps and pumps for 12 weeks after intensive treatment. The goal is to see if the new device can help maintain swelling reduction and improve daily life.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 98 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥ 18 years * Men and women * Unilateral lower limb lymphedema of stage II or III according to the criteria defined by the International Society of Lymphology * Patients completing an inpatient intensive treatment phase, including patients participating in CIV-25-01-050914, with a minimum of 20% of excess volume reduction * Patients who have given their informed consent freely and signed it prior to any intervention in the study. * Patients with a morphology compatible with the perimetric coverage of the device (calf and thigh). * Patients able to use the device * Patients enrolled in a social security plan or covered by similar health insurance. Exclusion Criteria: * Patients with suspended lymphoedema of the thigh (unaffected calf and foot) * Patients with lipedema * Patients with bilateral lower limb lymphoedema * Patients with a lymphedema associated with active cancer requiring acute chemotherapy, or oncologic relapses, or treatment in progress * Patients with contraindications for compression on the lower limbs such as stent/arterial graft in the area under compression * Peripheral artery disease ABI ≤ 0.6 * Advanced diabetic microangiopathy * Active deep/superficial active or recent venous thrombosis, phlegmasia ceruela dolens (painful blue inflammation), active venous leg ulcers, septic/acute thrombophlebitis of the limb (in the last 6 months) * A condition where increased venous or lymphatic return is undesirable * Neurological disease (including neurogenic diabetic foot, severe peripheral neuropathy of the limb) * Pulmonary embolism (last 6 months), pulmonary edema, poorly controlled asthma * Cardiac insufficiency (compensated or decompensated) * Implantable stimulation devices such as pacemaker * Chronic kidney disease with acute renal failure * Open skin lesions or skin and subcutaneous infection (cellulitis, erysipelas, lymphangitis, etc.) * Skin atrophy of the limb * Bullous dermatoses * Presence of subcutaneous osteosynthesis material with an external component lying subdermally at the level of the treated lower limb * Hyperalgesia of the foot, knee or hip * Patients with a known allergy to the components used in the device * Patients with psychiatric, psychological, or neurological disorders * Patients with impaired cognitive or motor skills and dependent individuals * Patients participating in another clinical trial * Pregnant or breastfeeding women. Women of childbearing potential will undergo Clearblue® urine pregnancy testing prior to enrollment to verify eligibility. * Vulnerable patients, adults being the object of a legal protective measure or unable to express their consent * Patients unable to submit to the constraints of the protocol

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    3 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU Montpellier - Saint Eloi

    Montpellier, 34090, France

  • CHU Toulouse - Rangueil

    Toulouse, 31059, France

  • Lympho-Opt Fachklinik fur Lymphologie

    Pommelsbrunn, Bavaria, 91224, Germany

    Contact Email: •••••@•••••

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