Feasibility Study for the SIRA-1000, SIRA® RFA Electrosurgical Device as an Adjunct to Breast Conserving Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Radiofrequency ablation alone, Radiofrequency ablation Electrosurgical Device.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Breast-conserving Surgery, Breast Cancer - Infiltrating Ductal Carcinoma, ER/PR+Her2neu. Basic parameters: from 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Feasibility Study for the SIRA-1000, SIRA® RFA Electrosurgical Device as an Adjunct to Breast Conserving Surgery
Overview
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.
Detailed description
During your surgery, after your lump is removed, the surgeon will place the SIRA-1000 in the breast cavity and perform the RF ablation procedure to treat the margins of the lumpectomy surgical site. A stitch will be used to stabilize and secure the tissue around the neck of the SIRA-1000 to ensure that contact is maintained between the SIRA-1000 electrode array and cavity tissue.
Upon completion of the RF ablation treatment, your tumor and the tissue samples from the ablated edges of the surgical site will be sent for review under a microscope (pathology).
After this, your surgery will be completed as standard, and your discharge will be determined by your medical team like any other surgery.
Interventions
- Device Radiofrequency ablation alone
Demonstrate the accuracy of the device to produce approximately 1 cm depth of ablation around the tumor bed, as evaluated by post-ablation tissue samples at least 1cm deep. - Device Radiofrequency ablation Electrosurgical Device
SIRA-1000 an radiofrequency ablation device, is designed to fit the post-lumpectomy cavity to provide uniform ablation.
Primary outcome measures
- To assess the safety of SIRA-1000 by summarizing the occurrence of Adverse Events. [Time frame: The study will span a total of approximately 12 months with a follow-up for 5 years.]
- Healing Process assessed by BREAST-Q Questionnaire [Time frame: 6 months]
Eligibility criteria
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
- Zubrod Performance Status of 0, 1, or 2
- No palpable lymphadenopathy
- Able and willing to provide written informed consent
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
- Current or history of breast implants
- Multi-centric or bilateral breast cancer
- Diffuse microcalcifications
- Participating in another ongoing clinical study in which concomitant diagnostic or therapeutic intervention that would reasonably be expected to alter the outcomes under study
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- University of Texas Medical Branch at Galveston, TX — Galveston
Publications
- Klimberg 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
Identifiers
NCT: NCT07206121 · 28001-CSP