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PEAK PlasmaBlade™ 4.0 Versus Traditional Electrosurgery in Lumpectomy

NCT00960154 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2013-01-08

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Medtronic Surgical Technologies

    lead INDUSTRY

Principal Investigators

  • Peter Naruns, MD · Midpeninsula Surgical Associates

  • Khoi Tran, MD · Palo Alto Medical Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00960154 on ClinicalTrials.gov