UTMB launches feasibility study of new device used during lumpectomy procedures

The University of Texas Medical Branch (UTMB) is enrolling patients in a U.S. feasibility study evaluating the investigational SIRA radiofrequency ablation device, an innovative technology designed for use during breast-conserving surgery.

Developed by Innoblative Designs, Inc., the device is engineered for intraoperative ablation of the post-lumpectomy cavity. Its spherical probe delivers radiofrequency energy circumferentially to achieve consistent ablation depth, with the goal of targeting microscopic residual cancer cells that may remain along the surgical margins.

The prospective, open-label, single-center study is being conducted in the UTMB Department of Surgery under the leadership of principal investigator Dr. Raj Vaghjiani.

"We are excited to evaluate this novel technology designed to treat the lumpectomy cavity during a breast-conserving procedure," Vaghjiani said. "This innovation offers a promising option that would allow us to address residual cancer in the surrounding tissue as part of the initial procedure, potentially eliminating the need for patients to undergo subsequent radiation therapy or reoperations."

He noted that a breast cancer diagnosis often brings fear, uncertainty, and difficult decisions, but the device may offer patients a more streamlined treatment experience.

"The ability to deliver intraoperative ablation with the SIRA device is a significant advancement that could reduce the overall treatment burden and improve the patient experience during this incredibly vulnerable time," he said. "We look forward to further validating this technology and generating the clinical evidence needed to support its role in the patient-centered breast cancer treatment paradigm."

Breast cancer remains a major global health concern. Many patients undergo breast-conserving therapy, which typically involves lumpectomy followed by several weeks of radiation. Roughly 1 in 5 patients requires a second procedure to address residual cancer, and radiation therapy can involve side effects that affect quality of life.

Through this feasibility study, UTMB investigators aim to determine whether intraoperative ablation can safely and effectively reduce the need for additional surgeries and radiation therapy. If successful, this approach could represent an important advancement in breast-conserving therapy, offering patients a more efficient treatment pathway while upholding the highest standards of cancer care.

For more information, or to participate in the study, please contact .