NCT07263451

Safety and Feasibility of IRE for Early-stage Breast Cancer: a Prospective, Open-Label, Single-Arm, Exploratory Study

Safety and Feasibility of Irreversible Electroporation for Early-stage Breast Cancer: a Prospective, Open-Label, Single-Arm, Exploratory Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Tian'an Jiang · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, open-label, single-arm, exploratory clinical trial conducted at our institution to investigate the use of Irreversible Electroporation (IRE) for the treatment of breast cancer.

Detailed description

This is a prospective, open-label, single-arm, exploratory clinical trial conducted at our institution to investigate the use of Irreversible Electroporation (IRE) for the treatment of breast cancer. Qualified patients will receive IRE ablation, followed by standard surgical resection. The efficacy and feasibility of IRE will be evaluated through statistical analysis of the outcomes, which will be recorded in accordance with the primary and secondary efficacy endpoints.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	IRE by stunning pulse therapy device	Qualified patients will receive IRE ablation, followed by standard surgical resection for breast cancer.During the process, patients will be followed up and evaluated

Timeline

• Start date: 2025-12-11
• Primary completion: 2026-03-15
• Completion: 2026-05-15
• First posted: 2025-12-04
• Last updated: 2025-12-22

Locations

2 sites across 1 country: China