Evaluation of Mobiderm Intimate Bra in the Management of Breast Edema Related to Breast Cancer Tr… (NCT06303154) | Clinical Trial Compass
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 range18 Years
SexFEMALE
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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.
What they're measuring
1
Evolution of breast edema severity
Timeframe: Between 35 and 44 weeks (6 months after radiotherapy)