Clinical trial · Interventional
Quality of Life in Patients With Standard External Compared to Custom-made Breast Prosthesis.
Study of the Quality of Life in Patients With Standard External Breast Prosthesis Compared to Patients With Custom-made Breast Prosthesis. MEAVANTI Project.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Despite improvements in surgical techniques, approximately 30% of mastectomies are still performed. Definitively or temporarily, one of the alternatives to restore a volume in the bra is the external breast prosthesis. The main objective is to evaluate whether the "custom-made" MEAVANTI prosthesis improves the quality of life of patients who have had a mastectomy compared to the external standard prosthesis.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MEAVANTI prothesis | Device | — | UNRESOLVED |
| Standard prothesis | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- MEAVANTI + Standard protheses
- description
- The patients will benefit from the experimental prothesis (MEAVANTI), after a wash-out period of 15 days, they will benefit from the standard non-adherent prothesis.
- interventionNames
- Device: MEAVANTI prothesis
- Device: Standard prothesis
- type
- OTHER
- label
- Standard + MEAVANTI protheses
- description
- The patients will benefit from the standard non-adherent prothesis, after a wash-out period of 15 days, they will benefit from the experimental prothesis (MEAVANTI).
- interventionNames
- Device: MEAVANTI prothesis
- Device: Standard prothesis
Primary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Unilateral mastectomy performed. * Satisfactory healing * Informed consent form signed. * Affiliate or beneficiary of a social security scheme Exclusion Criteria: * Elastomer type plastics or silicone allergy * Contraindication to the use of the MEAVANTI or Standard external prosthesis: damaged or irritated skin in the area of application of the prosthesis * Patient under the age of 18 years * History of back problems (scoliosis) * History of spine surgery * Other cancer being treated, * Dorsal hyperalgia * Acute infectious episode (cellulitis, erysipelas, lymphangitis) * Presence of subcutaneous osteosynthesis material with an external part at the level of the upper limb to be treated, * Impossibility to comply with the constraints of the protocol, * Pregnancy, * Breast feeding * Adult protected by law (tutelage, curators and safeguard of justice).
References
Publications (0)
Data not yet available