Status:
ACTIVE_NOT_RECRUITING
Single-Stage Prepectoral Placement of Textured Implants Using a Polyester Mesh Endoprostheses With Fluoropolymer Coating in Patients With Breast Cancer
Lead Sponsor:
Saint Petersburg State University, Russia
Conditions:
Breast Cancer
Breast Reconstruction
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
The study includes female patients aged 18 and above with a verified breast cancer diagnosis, ECOG performance status 0-1, and clinical stage T1-T3, N0-3, M0, who provide informed consent. Exclusion c...
Eligibility Criteria
Inclusion
- Women with a verified breast cancer diagnosis over 18 years of age;
- ECOG 0-1;
- Stage: clinical T1, T2 or T3, N0-3, M0;
- The thickness of subcutaneous adipose tissue (Pinch Test) is more than 5 mm
- Signed informed voluntary consent.
Exclusion
- Women under 18 years of age;
- ECOG 2-4;
- Stage: clinical T4, M1;
- The thickness of subcutaneous adipose tissue (Pinch Test) is less than 5 mm;
- Intolerance and / or allergic reaction to the mesh endoprosthesis, implant and/or its component;
Key Trial Info
Start Date :
May 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 15 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07185334
Start Date
May 15 2025
End Date
May 15 2027
Last Update
September 22 2025
Active Locations (1)
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1
Saint Petersburg State University
Saint Petersburg, Russia