Long-term results of phase II ablation after breast lumpectomy added to extend intraoperative margins (ABLATE l) trial.
V Suzanne Klimberg, Daniela Ochoa, Ronda Henry-Tillman...
https://pubmed.ncbi.nlm.nih.gov/24655863Actively Recruiting
Phase Not Applicable
Age: 50Years +
FEMALE
ID07206121
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
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and clinical accuracy of the SIRA-1000, a radiofrequency ablation (RFA) electrosurgical device, in patients undergoing breast conserving surgery for breast cancer. The study focuses on using RFA to treat the margins surrounding the tumor site after lumpectomy, aiming to destroy remaining cancer cells in the tissue around the lump. This feasibility study is designed for women diagnosed with specific types of breast cancer, including infiltrating ductal carcinoma with certain hormone receptor statuses and tumor grades. During surgery, after the tumor is removed, the surgeon will place the SIRA-1000 device into the breast cavity and perform the RFA procedure to ablate the tissue margins around the surgical site. The device is secured with a stitch to maintain contact with the tissue. After ablation, tissue samples including the tumor and ablated edges are sent for microscopic examination. The surgery then proceeds as standard, with patient discharge based on routine post-surgical care. Participants will be monitored for safety by tracking adverse events over approximately 12 months, with follow-up extending up to five years. Healing will be assessed using the BREAST-Q Questionnaire at six months. The study involves tissue evaluations and patient-reported outcomes to measure recovery and treatment safety. Overall, the trial spans multiple years of observation to gather comprehensive data on the device's performance and patient healing.
CONDITIONS
Brief Title
Feasibility Study for the SIRA-1000, SIRA® RFA Electrosurgical Device as an Adjunct to Breast Conserving Surgery
Who Can Participate
Age: 50Years +
FEMALE
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+Her2neu-, Grade I, II, or III
- Unicentric, unilateral tumor size 3 cm or less
- Tumor located at least 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
You will not qualify if you...
- Pregnant or breastfeeding
- Receiving neoadjuvant chemotherapy
- 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 clinical study with interventions that could affect outcomes
- Any condition or situation that may pose significant risk, confound results, or interfere with participation as judged by the Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Day of surgery
Participants undergo breast conserving surgery. During surgery, the SIRA-1000 radiofrequency ablation device is placed in the breast cavity to treat the margins of the lumpectomy site. Surgery is completed as standard and discharge is determined by the medical team.
1 surgical visit (in-person)
Post-operative Follow-up
Duration - Up to 12 months with follow-up for 5 years
Participants are monitored for safety and healing after the surgery and device treatment, including assessment of adverse events and healing process using questionnaires.
Regular follow-up visits over 12 months and annual visits up to 5 years
Trial Site Locations
Total: 1 location
1
University of Texas Medical Branch at Galveston, TX
Galveston, Texas, United States, 60612
Actively Recruiting
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Research Team
C
Clinical Trials Manager
V
VP Quality Assurance & Regulatory Affairs
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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