Feasibility Study for the SIRA-1000, SIRA® RFA Electrosurgical Device as an Adjunct to Bre
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 controll
| Condition(s) | Breast Cancer, Breast-conserving Surgery, Breast Cancer - Infiltrating Ductal Carcinoma, ER/PR+Her2neu, Grade I, II, III |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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 ongoi |
| Ages | 50 Years |
| Sex | Female |
| Lead sponsor | Innoblative Designs, Inc. |
| Locations | Galveston, Texas, United States |
| Start date | 2026-02-10 |
| NCT ID | NCT07206121 |
| Official listing | https://clinicaltrials.gov/study/NCT07206121 |