Active — Not RecruitingNot Applicable

Evaluation of Mobiderm Intimate Bra in the Management of Breast Edema Related to Breast Cancer Treatment

France30 participantsStarted 2024-03-21

Plain-language summary

The aim of this exploratory study is to assess the performance and tolerability of the MOBIDERM Intimate Bra in the management of breast edema related to breast cancer treatment.

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: * Females aged 18 years and older. * Patients who have undergone conserving surgery for breast cancer. * Patients scheduled to undergo radiation treatment of the breast/chest wall within the next 12 weeks after surgery. * Patients with a morphology compatible with the proposed sizes of the devices, including bust girth and cup size. * Patients who have signed an informed consent form prior to any study intervention. * Patients with full legal capacity and enrolled in a social security system or covered by a similar health insurance. Exclusion Criteria: * Patients with an A cup bra size. * Patients with infected or acutely inflammatory skin on the chest. * Patients who require chemotherapy during the follow-up period. * Pregnant women or women of childbearing age without adequate contraception or in the lactation period. * Participation in other clinical trials that impact the primary endpoint. * Patients with a known allergy to the investigational device components. * Patients with psychiatric, psychological, or neurological disorders that are incompatible with the conduct of a clinical trial. * Patients unable to be followed for 12 months. * Vulnerable patients, or those subject to a judicial protection measure or unable to provide informed consent freely.

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

Evolution of breast edema severity

Timeframe: Between 35 and 44 weeks (6 months after radiotherapy)

Trial details

NCT IDNCT06303154

SponsorThuasne

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-09

View on ClinicalTrials.gov More Breast Cancer Surgery trials