NCT06817954

To Evaluate the Effectiveness and Safety of Mastectomy Combined With Immediate Breast Reconstruction in Breast Cancer

A Prospective, Single-center, Double-arm Clinical Study to Evaluate the Effectiveness and Safety of Mastectomy Combined With Immediate Breast Reconstruction in Breast Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The new technology of endoscopic-assisted system, as an emerging technology, has shown certain application prospects in breast surgery. However, the new technology of endoscopic-assisted mastectomy and immediate breast reconstruction in China in the treatment of breast cancer is still in the exploratory stage and needs to be further improved. This prospective, single-center, double-arm clinical study was conducted to use the endoscopic-assisted system and evaluate the effectiveness and safety of the mastectomy combined with immediate breast reconstruction in breast cancer.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	endoscopic-assisted mastectomy and immediate breast reconstruction	endoscopic-assisted mastectomy and sentinel lymph node biopsy/axillary lymph node dissection in the management of breast cancer
PROCEDURE	mastectomy and immediate breast reconstruction	conventional mastectomy and sentinel lymph node biopsy/axillary lymph node dissection in the management of breast cancer

Timeline

• Start date: 2025-01-01
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2025-02-10
• Last updated: 2025-02-10

Locations

1 site across 1 country: China