Clinical Study to Assess the Efficacy and Pressure Maintenance of MOBIDERM Autofit Versus Bandage… (NCT07355959) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical Study to Assess the Efficacy and Pressure Maintenance of MOBIDERM Autofit Versus Bandages in the Management of Breast Cancer Related Lymphedema (BCRL) in Night-time Maintenance Phase.
Germany16 participantsStarted 2026-01-15
Plain-language summary
The aim of this cross-over, randomized study is to assess the efficacy and pressure maintenance of MOBIDERM Autofit versus bandages in the management of Breast Cancer Related Lymphedema (BCRL) in night-time maintenance phase.
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
. Age ≥ 18 years
. Unilateral upper limb lymphedema of stage I, II or III according to the criteria defined by the International Society of Lymphology, following breast cancer
. Patient in maintenance phase of lymphedema treatment
. Affected arm that fits with one of the standard sizes of the Auto- Adjustable MOBIDERM Autofit provided.
. Signed informed consent prior to any study-mandated procedure.
Exclusion criteria
. Active cellulitis / Infectious dermo-hypodermatitis
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
Volume excess variation
Timeframe: 2 months (Inclusion, first month and second month visit)
. Lymphedema associated with active cancer needing acute chemotherapy
. Motor and sensitive neurological deficiency / psychiatric or addictive disorders
. Patients for whom compression is contraindicated, such as untreated infections, skin irritation, thrombosis: presence of skin lesions on the sleeve placement
. Pregnant or breastfeeding patient
. Participation to any other clinical study which has an impact on the different endpoints
. Vulnerable patient, adults being the object of a legal protective measure or enable to express their consent.