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PEAK PlasmaBlade™ 4.0 Versus Traditional Electrosurgery in Lumpectomy

2014-07-23 21:13:37 | BioPortfolio

Summary

The objective of this clinical study is to evaluate the operative performance of the PEAK PlasmaBlade 4.0 during lumpectomy; to monitor and record thermal injury depth at the surgical margin and need for additional tissue excision; and to compare these endpoints to the current standard of care.

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 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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Conditions

Lumpectomy

Intervention

PEAK PlasmaBlade, Traditional Electrosurgery with scalpel

Location

El Camino Surgery Center
Mountain View
California
United States
94040

Status

Enrolling by invitation

Source

Peak Surgical, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:13:37-0400

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