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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Histological Metrics: Amount of Overlying Adherent Char on Slide; Damage to Tumor Epithelium; Effect of Electrosurgical Damage on Diagnostic Quality of Lumpectomy Specimen
Overall histological quality score will be a composite of the histological metrics
Peter Naruns, MD
Midpeninsula Surgical Associates
United States: Institutional Review Board
|Palo Alto Medical Foundation||Palo Alto, California 94301|
|El Camino Surgery Center||Mountain View, California 94040|