NCT07206121Recruiting
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 · Last updated 11 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 18 Sept 2025
- Start date
- 10 Feb 2026
- Primary completion date
- 6 Feb 2027
- Lead sponsor
- Innoblative Designs, Inc.
- NCT number
- NCT07206121
What you commit to
- Study type: Interventional
- Planned participants: 10
- From 10 Feb 2026 to the primary completion date, 6 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Neoadjuvant chemotherapy
- Participating in another ongoing clinical study in which concomitant diagnostic or therapeutic intervention that would reasonably be expected to alter the outcomes under study
Other illness
- Cardiac arrhythmia
- Patients with active implantable medical devices, such as implanted cardiac pacemakers or defibrillators, or any other electronic device
- Current or history of breast implants
- Multi-centric or bilateral breast cancer
- 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.
Other
- Pregnant or breastfeeding
- Diffuse microcalcifications
Who the study is looking for
- 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
- Zubrod Performance Status of 0, 1, or 2
- No palpable lymphadenopathy
- Able and willing to provide written informed consent
Age in the registry: 50 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Texas Medical Branch at Galveston, TX Coordinator of this site? Confirm its status | Galveston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.