Actively Recruiting
Feasibility Study for the SIRA-1000, SIRA® RFA Electrosurgical Device as an Adjunct to Breast Conserving Surgery
Led by Innoblative Designs, Inc. · Updated on 2026-02-11
10
Participants Needed
1
Research Sites
312 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Feasibility Study for the SIRA-1000, SIRA® RFA Electrosurgical Device as an Adjunct to Breast Conserving Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biologic female
- 50 years of age and older
- Confirmed diagnosis of breast cancer: infiltrating ductal carcinoma, ER/PR positive, Her2neu negative
- Tumor grade I, II, or III
- Unicentric, unilateral tumor size 3 cm or less
- Tumor located at least 2 cm away from skin and other structures
- Zubrod Performance Status of 0, 1, or 2
- No palpable lymphadenopathy
- Able and willing to provide written informed consent
You will not qualify if you...
- Pregnant or breastfeeding
- Receiving neoadjuvant chemotherapy
- Having cardiac arrhythmia
- Having active implantable medical devices such as pacemakers or defibrillators
- Current or history of breast implants
- Multi-centric or bilateral breast cancer
- Diffuse microcalcifications
- Participating in another ongoing clinical study with interventions that may affect outcomes
- Conditions or situations that may put the participant at significant risk or interfere with study participation as judged by the Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Texas Medical Branch at Galveston, TX
Galveston, Texas, United States, 60612
Actively Recruiting
Research Team
C
Clinical Trials Manager
CONTACT
V
VP Quality Assurance & Regulatory Affairs
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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