Trial Information

A Prospective, Randomized, Controlled Study to Evaluate Use of the PEAK PlasmaBladeTM 4.0 in Breast Lumpectomy

Lumpectomy is a surgical procedure performed to remove a localized mass of breast tissue
that is suspicious for malignancy. The purpose of lumpectomy is to minimize the amount of
tissue removed from the breast to retain normal breast architecture while simultaneously
removing all of the suspected cancerous tissue. Typically, a scalpel is used for the skin
incision and a traditional electrosurgical device is used to cut away any cancerous tissue.

The PEAK PlasmaBlade™ uses pulsed radiofrequency (RF) energy and a highly-insulated
handpiece design to enable precision cutting and coagulation at the point of application.
The PlasmaBlade has received FDA clearance for use in plastic, general, and ear, nose, and
throat (ENT) surgery, and has demonstrated a significantly reduced thermal injury profile in
incised tissue compared to traditional electrosurgical devices. It is hypothesized that
this benefit may improve the pathological analysis of excised breast lumps.

This single site study was granted Institutional Review Board (IRB) approval and conducted
between June 2009 and January 2011. Potential subjects were screened against the inclusion
and exclusion criteria of the study protocol and were then required to provide informed
consent prior to enrollment. Following enrollment, subjects were prospectively randomized to
the SOC or PEAK PlasmaBlade study groups and scheduled for lumpectomy.