Status:
NOT_YET_RECRUITING
Feasibility Study for the SIRA-1000, SIRA® RFA Electrosurgical Device as an Adjunct to Breast Conserving Surgery
Lead Sponsor:
Innoblative Designs, Inc.
Conditions:
Breast Cancer
Breast-conserving Surgery
Eligibility:
FEMALE
50+ years
Phase:
NA
Brief 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 b...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2031
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT07206121
Start Date
November 1 2025
End Date
November 1 2031
Last Update
October 9 2025
Active Locations (1)
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1
University of Texas Medical Branch at Galveston, TX
Galveston, Texas, United States, 60612