NCT00960154

PEAK PlasmaBlade™ 4.0 Versus Traditional Electrosurgery in Lumpectomy

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Medtronic Surgical Technologies · Industry
• Sex: Female
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	PEAK PlasmaBlade	The entirety of the lumpectomy will be performed with the PEAK PlasmaBlade including the skin incision
PROCEDURE	Traditional Electrosurgery with scalpel	The skin incision will be performed using a standard scalpel; the subcutaneous dissection will be performed with traditional electrosurgery using the Cut and Coagulation modes.

Timeline

• Start date: 2009-07-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2009-08-17
• Last updated: 2013-01-08
• Results posted: 2013-01-03

Locations

2 sites across 1 country: United States