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Active, not recruiting Not applicable

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

NCT06303154 · tracked via the Priya Life Science France tracker
Sponsor
Phase
Not applicable
Started
2024-03-21
Last updated
2025-09-10

Condition(s) studied

Breast Cancer Surgery

Investigational drug(s) / intervention(s)

Mobiderm Intimate Bra group

Mobiderm Intimate Bra group: At the conclusion of the surgical operation, MOBIDERM Intimate bra will be placed on the patient by the medical team. It will be recommended for the patients to wear MOBIDERM Intimate Bra during day and night for 3 weeks after the surgery, and as much time as the patients tolerate the device during the rest of the study, until 6 months after radiotherapy

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Evolution of breast edema severity — Between 35 and 44 weeks (6 months after radiotherapy)
    The evolution of breast edema severity will be assessed all along the study follow-up using the patient-completed "Symptoms" section of the Breast Edema Questionnaire (BrEQ): 8 questions about symptoms of breast edema scored on a scale from 0 to 10 (0 = no difficulty and 10: maximal difficulty). The maximum score is 80 .

Trial sites (1)

FacilityCityRegionStatus
Groupe Hospitalier Paris Saint Joseph - Groupement FEHAP Paris Paris 14
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06303154 on ClinicalTrials.gov ↗ ← All trials in France