NCT04389216

Radiofrequency Ablation (RFA) in Breast Tumors

Radiofrequency Ablation in Breast Tumors in Early Stages

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Hospital Universitari de Bellvitge · Academic / Other
• Sex: Female
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

To validate the efficacy and safety of the cool-tip ablation method for breast tumors smaller than 2 cm.

Detailed description

A prospective, phase II-III study, which will include a series of cases of 30 patients. The hospitals involved will be Bellvitge University Hospital and Hospital del Mar. Efficacy was evaluated according magnetic resonance image and biopsy of the breast 1 month after the procedure. Patients will be followed up over a 2-year period to assess cosmetic results, short and long-term complications and possible recurrences.

Conditions

• Breast Cancer Female

Interventions

Type	Name	Description
DEVICE	Cool-tip electrode for Radiofrequency Ablation	Radiofrequency ablation of the tumour in the surgery group, associated whith axillary surgery when applicable

Timeline

• Start date: 2020-05-01
• Primary completion: 2025-09-09
• Completion: 2025-09-09
• First posted: 2020-05-15
• Last updated: 2025-09-15

Locations

2 sites across 1 country: Spain

Regulatory

• FDA-regulated device study