Termination due to acquisition of PEAK Surgical by Medtronic

The purpose of this clinical study is to quantify the difference in thermal injury depth at the surgical margin in breast lumpectomy specimens excised with the PlasmaBlade; to subjectively assess histopathologic sample quality metrics; to examine the role that electrosurgical artifact may play in revision lumpectomy procedures; and to compare these endpoints to the standard of care (SOC) technology.

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.

Inclusion Criteria:

1. Age between 18 and 90 years old
2. Physically healthy, stable weight
3. Requiring lumpectomy with wire localization for suspected or confirmed malignant breast disease.
4. Subject must understand the nature of the procedure and provide written informed consent prior to the procedure.
5. Subject must be willing and able to comply with all follow-up evaluations

Exclusion Criteria:

1. Age younger than 18 or greater than 90 years old
2. Infection (local or systemic)
3. Cognitive impairment or mental illness
4. Severe cardiopulmonary deficiencies
5. Unable to follow instructions or complete follow-up
6. Currently taking any medication known to affect healing
7. Currently enrolled in another investigational device or drug trial

Upon Medtronic's acquisition of PEAK surgical, a study integrity audit was undertaken. Results of the audit showed that patient's rights and safety were maintained, but the source data, including baseline demographics, were unverifiable.