Clinical Research Hub

Advancing the Standard of Care in Breast-Conserving Surgery

Clinical Research Hub | Innoblative

Innoblative is committed to building a robust foundation of clinical evidence for the SIRA® RFA Electrosurgical Device through collaboration with world-class institutions and rigorous scientific study.

U.S. Clinical Program

Feasibility Pilot Study (UTMB): Post-Lumpectomy Ablation

We are proud to announce that the Institutional Review Board (IRB) at the University of Texas Medical Branch (UTMB) has approved our feasibility pilot study evaluating ablation following lumpectomy.

The study is led by Dr. Raj Vaghjiani, Assistant Professor in the Department of Surgery at the UTMB Cancer Center, who will serve as Principal Investigator. Patient recruitment is now underway.

This prospective study is designed to assess the safety and feasibility of delivering ablation therapy following breast-conserving surgery. The goal is to generate important clinical data that may help inform future treatment strategies and improve outcomes for patients undergoing lumpectomy.

IRB approval represents a key milestone in our clinical development program and reflects our commitment to rigorous scientific evaluation and collaboration with leading academic institutions.

Visit ClinicalTrials.gov NCT07206121

Investigator Participation Opportunities

We are currently engaging leading breast cancer centers to participate in our upcoming pivotal trial evaluating intraoperative radiofrequency ablation as an adjunct to breast-conserving surgery.

Participating sites will have the opportunity to:

Contribute to a landmark study in breast cancer treatment
Gain early experience with the SIRA® RFA Electrosurgical Device
Collaborate with a network of leading investigators

If you are interested in participating, please complete the contact form.

Complete Form Here

Investigator-Initiated Trials (IIT)

Italian IIT

We are pleased to announce that ethics committee approval has been granted for an investigator-initiated trial (IIT) in Italy evaluating post-lumpectomy ablation in patients undergoing breast-conserving surgery.

The study will be led by Dr. Stefano Spinaci, a leading breast surgeon in Italy, and will assess the feasibility and safety of delivering intraoperative ablation following lumpectomy.

By creating an additional zone of tumor destruction around the lumpectomy cavity, the approach aims to improve local tumor control while generating clinical evidence to explore whether radiation therapy (RT) may be safely reduced or de-escalated in selected patients.

Regulatory Milestones

AMA Category III CPT® Code: The American Medical Association has approved a dedicated CPT code for intraoperative radiofrequency ablation of the breast cavity.

Read Press Release

FDA Breakthrough Device Designation: Received for the SIRA® RFA Electrosurgical Device, recognizing its potential to provide more effective treatment for life-threatening or irreversibly debilitating diseases.

How It Works

The SIRA® RFA Electrosurgical Device is designed specifically for use in breast-conserving surgery. Watch the animation below to see how SIRA® delivers uniform intraoperative radiofrequency ablation around the lumpectomy cavity to extend surgical margins and improve local tumor control.

Pre-Clinical Data

ASBRS 2023 Poster ASBRS 2023 Abstract SABCS 2021 Abstract SABCS 2020 Abstract SABCS 2020 Poster Bailey, et al, Surg Onc 2025

BCS + RFA

Breast-Conserving Surgery and Radiofrequency Ablation

Learn more about the clinical rationale for combining radiofrequency ablation with breast-conserving surgery, and the body of evidence supporting this approach.

Explore BCS + RFA