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

Summary

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.

Eligibility

Inclusion Criteria:

1. Biologic female
2. 50 years of age and older
3. Confirmed diagnosis of breast cancer:

   1. Infiltrating ductal carcinoma
   2. ER/PR+Her2neu-
   3. Grade I, II, or III
4. Unicentric, unilateral tumor size ≤ 3cm
5. Tumor location ≥ 2 cm from skin and other structures
6. Zubrod Performance Status of 0, 1, or 2
7. No palpable lymphadenopathy
8. Able and willing to provide written informed consent

Exclusion Criteria:

1. Pregnant or breastfeeding
2. Neoadjuvant chemotherapy
3. Cardiac arrhythmia
4. Patients with active implantable medical devices, such as implanted cardiac pacemakers or defibrillators, or any other electronic device
5. Current or history of breast implants
6. Multi-centric or bilateral breast cancer
7. Diffuse microcalcifications
8. Participating in another ongoing clinical study in which concomitant diagnostic or therapeutic intervention that would reasonably be expected to alter the outcomes under study
9. Has a condition or is in a situation which in the Investigator's opinion may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.

Conditions6

Locations1 site

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