Clinical trial · Interventional
Feasibility Study for the SIRA-1000, SIRA® RFA Electrosurgical Device as an Adjunct to Breast Conserving Surgery
A Feasibility Study for the SIRA-1000, SIRA® RFA Electrosurgical Device as an Adjunct to Breast Conserving Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Cancer - Infiltrating Ductal Carcinoma | — | UNRESOLVED | — |
| Breast-conserving Surgery | — | UNRESOLVED | — |
| ER/PR+Her2neu | — | UNRESOLVED | — |
| Grade I, II, III | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiofrequency ablation alone | Device | — | UNRESOLVED |
| Radiofrequency ablation Electrosurgical Device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Feasibility and safety study for women undergoing BCS.
- description
- RFA electrosurgical device as an adjunct to BCS.
- interventionNames
- Device: Radiofrequency ablation alone
- Device: Radiofrequency ablation Electrosurgical Device
Primary outcomes (2)
- measure
- To assess the safety of SIRA-1000 by summarizing the occurrence of Adverse Events.
- timeFrame
- The study will span a total of approximately 12 months with a follow-up for 5 years.
- description
- Assess the occurrence adverse events and to evaluate the impact of RFA on healing process.
- measure
- Healing Process assessed by BREAST-Q Questionnaire
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDKlimberg VS, Ochoa D, Henry-Tillman R, Hardee M, Boneti C, Adkins LL, McCarthy M, Tummel E, Lee J, Malak S, Makhoul I, Korourian S. Long-term results of phase II ablation after breast lumpectomy added to extend intraoperative margins (ABLATE l) trial. J Am Coll Surg. 2014 Apr;218(4):741-9. doi: 10.1016/j.jamcollsurg.2013.12.032. Epub 2014 Jan 11. PMID 24655863