Feasibility Study for the SIRA-1000, SIRA® RFA Electrosurgical Device as an Adjunct to Breast Con… (NCT07206121) | Clinical Trial Compass
RecruitingNot Applicable
Feasibility Study for the SIRA-1000, SIRA® RFA Electrosurgical Device as an Adjunct to Breast Conserving Surgery
United States10 participantsStarted 2026-02-10
Plain-language 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
Age range50 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Biologic female
✓. 50 years of age and older
✓. Confirmed diagnosis of breast cancer:
✓. Infiltrating ductal carcinoma
✓. ER/PR+Her2neu-
✓. Grade I, II, or III
✓. Unicentric, unilateral tumor size ≤ 3cm
✓. Tumor location ≥ 2 cm from skin and other structures
Exclusion criteria
✕. Pregnant or breastfeeding
✕. Neoadjuvant chemotherapy
✕. Cardiac arrhythmia
✕. Patients with active implantable medical devices, such as implanted cardiac pacemakers or defibrillators, or any other electronic device
What they're measuring
1
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.
2
Healing Process assessed by BREAST-Q Questionnaire
✕. Participating in another ongoing clinical study in which concomitant diagnostic or therapeutic intervention that would reasonably be expected to alter the outcomes under study