Feasibility Study for the SIRA-1000, SIRA® RFA Electrosurgical Device as an Adjunct to Breast Conserving Surgery

This study aims to assess the safety and clinical accuracy of the SIRA-1000, SIRA® RFA Electrosurgical Device in ablating margins post-lumpectomy in patients undergoing breast conserving surgery for breast cancer. Radiofrequency ablation, or RFA, uses radio waves to create heat, that in turn, causes deliberate controlled damage to the tissue surrounding where the tumor was located. You may hear your doctor refer to this as the 'margins'. Your doctor is using this treatment to help destroy remaining cancer cells in the margins around the site of the lump.

NCT Number	NCT07206121
Lead Sponsor	Innoblative Designs, Inc.
Conditions	Breast Cancer, Breast-conserving Surgery, Breast Cancer - Infiltrating Ductal Carcinoma, ER/PR+Her2neu, Grade I, II, III
Enrollment	10 participants
Start Date	2026-02-10
Primary Completion	2027-02-06 (estimated)
Study Completion	2032-02-06 (estimated)
Updated on ClinicalTrials.gov	2026-02-11