Clinical trial announcement: A new study assessing the SIRA-1000 electrosurgical device’s potential as an adjunct to breast-conserving surgery will begin soon. This feasibility study, sponsored by Innoblative Designs, Inc., aims to explore the effectiveness and safety of radiofrequency ablation (RFA) technology for treating specific breast cancer types. Professionals in the clinical, quality, and regulatory fields should take note of this exciting development in the medical device landscape.
In this article:
- What changed?
- What are the trial details?
- Who is affected?
- FAQ
- Conclusion
- Disclaimer
- Announcement link
What changed?
On October 5, 2025, Innoblative Designs, Inc. announced its plan to commence the feasibility study for the SIRA-1000 electrosurgical device. This device utilizes radiofrequency ablation technology to improve outcomes in breast-conserving surgery. The trial is currently listed as “not yet recruiting” on ClinicalTrials.gov, signaling that enrollment is forthcoming. The study represents a step forward in addressing unmet needs of surgical precision and post-operative breast cancer management.
What are the trial details?
Device under study
The SIRA-1000 is a radiofrequency ablation (RFA) electrosurgical device. The trial will compare two intervention approaches: RFA alone and RFA with adjunct electrosurgical techniques. Its intended purpose is to serve as an adjunct to standard surgical procedures, potentially enhancing tumor eradication and preserving healthy tissue.
Target conditions
This feasibility study targets patients diagnosed with breast cancer, including infiltrating ductal carcinoma. Eligible participants will have hormone receptor-positive cancers (ER/PR+Her2neu) in grade I, II, or III classifications.
Sponsorship and regulatory oversight
The trial is sponsored by Innoblative Designs, Inc., a company specializing in innovative RFA solutions for oncology applications. As listed on ClinicalTrials.gov, the study is in the initial stages and has yet to begin recruiting participants.
Who is affected?
The clinical community, including oncologists, breast surgeons, and regulatory specialists, should be aware of this trial. Quality and compliance teams may need to monitor developments closely as the study progresses. Patients who qualify for this trial could gain access to a potentially groundbreaking treatment option.
FAQ
- 1. What is radiofrequency ablation?
Radiofrequency ablation is a minimally invasive technology using thermal energy to target abnormal tissues, such as tumors. - 2. What makes this device unique?
The SIRA-1000 combines traditional surgical methods with RFA to enhance breast-conserving procedures. - 3. When does recruitment begin?
Recruitment is not yet open, but updates will follow on ClinicalTrials.gov. - 4. Who is eligible?
Patients with breast cancer types listed under ER/PR+Her2neu, grades I–III, may qualify. - 5. How can professionals stay updated?
Bookmark ClinicalTrials.gov for trial progress.
Conclusion
The SIRA-1000 feasibility study reflects promising advancements in breast cancer care. Regulatory professionals and clinicians should track its progress closely. Stay informed of upcoming trial stages to better evaluate its impact on patient outcomes.
Disclaimer
This post is for informational purposes only. It does not constitute legal advice or clinical recommendations. Always consult with a qualified professional for decision-making and compliance matters.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07206121?term=medical+device