Feasibility Study for the SIRA-1000, SIRA® RFA Electrosurgical Device as an Adjunct to Breast Conserving Surgery

N/ARecruitingNCT07206121

Innoblative Designs, Inc.10 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Breast Cancer Breast-conserving Surgery

Interventions

Radiofrequency ablation aloneDEVICE

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.

Radiofrequency ablation Electrosurgical DeviceDEVICE

SIRA-1000 an radiofrequency ablation device, is designed to fit the post-lumpectomy cavity to provide uniform ablation.

Eligibility

Sex: FEMALEMin age: 50 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

To assess the safety of SIRA-1000 by summarizing the occurrence of Adverse Events.

Assess the occurrence adverse events and to evaluate the impact of RFA on healing process.

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

Assess healing process using cosmesis and quality of life patient reported outcomes.

Time frame: 6 months