Feasibility Study for the SIRA-1000, SIRA® RFA Electrosurgical Device as an Adjunct to Breast Conserving Surgery
NCT07206121
This study is recruiting at 1 US site in 1 state, according to its ClinicalTrials.gov record last updated .
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 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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Breast Cancer
- Breast-conserving Surgery
- Breast Cancer - Infiltrating Ductal Carcinoma
- ER/PR+Her2neu
- Grade I, II, III
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Not applicable
- Ages
- 50 years and older
- Sex
- Female
- Healthy volunteers
- Not accepted
- Sponsor
- Innoblative Designs, Inc.
- Last updated on ClinicalTrials.gov
- February 11, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Texas · 1
- University of Texas Medical Branch at Galveston, TX · Galveston, TX
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.