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New adjustable sleeve could ease lymphedema at night

NCT ID NCT07355959

Symptom relief Sponsor: Thuasne Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether a new adjustable sleeve called MOBIDERM Autofit works better than standard bandages for managing breast cancer-related lymphedema at night. Sixteen women with arm swelling will wear each device for one month to compare changes in arm volume and pressure. The goal is to find a simpler, more effective nighttime option.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MOBIDERM Autofit armsleeve (a wearable device)
What this could lead to
If it works, this could offer a more convenient and effective way to manage lymphedema at night, reducing arm swelling and improving comfort.
What could go wrong
This is a very small early-stage trial with only 16 participants, so results may not apply broadly. The device may not maintain pressure as well as bandages, or may cause discomfort.

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 16 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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

Female participants only

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: 1. Age ≥ 18 years 2. Unilateral upper limb lymphedema of stage I, II or III according to the criteria defined by the International Society of Lymphology, following breast cancer 3. Patient in maintenance phase of lymphedema treatment 4. Affected arm that fits with one of the standard sizes of the Auto- Adjustable MOBIDERM Autofit provided. 5. Signed informed consent prior to any study-mandated procedure. Exclusion Criteria: 1. Active cellulitis / Infectious dermo-hypodermatitis 2. Lymphedema associated with active cancer needing acute chemotherapy 3. Motor and sensitive neurological deficiency / psychiatric or addictive disorders 4. Patients for whom compression is contraindicated, such as untreated infections, skin irritation, thrombosis: presence of skin lesions on the sleeve placement 5. Pregnant or breastfeeding patient 6. Participation to any other clinical study which has an impact on the different endpoints 7. Vulnerable patient, adults being the object of a legal protective measure or enable to express their consent.

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Conditions

The condition(s) this trial relates to.

lymphedema

As listed by the trial registrant

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

Limb lymphoedema Unilateral upper limb lymphedema

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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

  • Ödemzentrum Bad Berleburg Klinik

    Bad Berleburg, 57319, Germany