Clinical trial · Interventional
Single-Stage Prepectoral Placement of Textured Implants Using a Polyester Mesh Endoprostheses With Fluoropolymer Coating in Patients With Breast Cancer
NCT07185334CI-TRIAL-00095533FluoropolyMeshactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study aims to evaluate the efficacy of using a polyester mesh endoprosthesis with a fluoropolymer coating in reducing postoperative complications, particularly protrusions, following subcutaneous mastectomy with simultaneous prepectoral placement of textured breast implants in women with breast cancer
Conditions
Conditions (5)
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 |
| Breast Reconstruction | — | UNRESOLVED | — |
| Coated Materials | — | UNRESOLVED | — |
| MASH With Fibrosis | — | UNRESOLVED | — |
| Reconstruction Breast Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Subcutaneous mastectomy using a fluoropolymer-coated polyester mesh endoprosthesis with simultaneous prepectoral placement of textured implants. | Procedure | — | UNRESOLVED |
| Subcutaneous mastectomy with simultaneous prepectoral placement of textured implants. | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Main group
- description
- The main group will consist of patients with the planned volume of surgical intervention: subcutaneous mastectomy using a polyester mesh endoprosthesis with a fluoropolymer coating and simultaneous prepectoral placement of textured implants.
- interventionNames
- Procedure: Subcutaneous mastectomy using a fluoropolymer-coated polyester mesh endoprosthesis with simultaneous prepectoral placement of textured implants.
- type
- OTHER
- label
- Control group
- description
- The control group will consist of patients who undergo surgical treatment for subcutaneous mastectomy, with simultaneous placement of textured breast implants with no polyester mesh endoprosthesis with a fluoropolymer coating
- interventionNames
- Procedure: Subcutaneous mastectomy with simultaneous prepectoral placement of textured implants.
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women with a verified breast cancer diagnosis over 18 years of age; 2. ECOG 0-1; 3. Stage: clinical T1, T2 or T3, N0-3, M0; 4. The thickness of subcutaneous adipose tissue (Pinch Test) is more than 5 mm 5. Signed informed voluntary consent. Exclusion Criteria: 1. Women under 18 years of age; 2. ECOG 2-4; 3. Stage: clinical T4, M1; 4. The thickness of subcutaneous adipose tissue (Pinch Test) is less than 5 mm; 5. Intolerance and / or allergic reaction to the mesh endoprosthesis, implant and/or its component;
References
Publications (0)
Data not yet available
No reference posted for this study.