Informations générales (source: ClinicalTrials.gov)
Evaluation of the Performance and Safety of Mobiderm Intimate Bra in the Management of Breast Edema Related to Breast Cancer Treatment - A Prospective, Exploratory, Monocentric, Uncontrolled Clinical Study (MOBIBRA)
Interventional
N/A
Thuasne (Voir sur ClinicalTrials)
mars 2024
septembre 2025
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| GH PARIS SITE SAINT JOSEPH | Séverine ALRAN, Dr | Contact (sur clinicalTrials) | |||
Critères
Femme
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.
- 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.
- 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.