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PEAK PlasmaBlade™ 4.0 Versus Traditional Electrosurgery in Mastectomy

NCT00943605 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2013-01-08

Study results available
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Summary

The objective of this clinical study is to evaluate the incidence of partial skin necrosis following modified-radical mastectomy with or without same-day (two-stage) reconstruction with the PEAK PlasmaBlade 4.0; to monitor and record operative performance, post-operative pain, drain output, and skin scarring following surgery; and to compare these endpoints to the current standard of care (SOC).

Conditions

  • Mastectomy

Interventions

DEVICE

Scalpel and Traditional Electrosurgery

The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.

DEVICE

PEAK PlasmaBlade

The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision.

Sponsors & Collaborators

  • Medtronic Surgical Technologies

    lead INDUSTRY

Principal Investigators

  • Teresa Ponn, MD · Elliot Breast Health Center

  • Edward Dalton, MD · Elliot Breast Health Center

  • Richard Fine, MD · Advanced Breast Care

  • Peter Naruns, MD · Midpeninsula Surgical Associates

  • Saul Eisenstat, MD · Midpeninsula Surgical Associates

  • Michael Schultz, MD · St. Joseph Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2011-12-31
Completion
2012-03-31

Countries

  • United States

Study Locations

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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 NCT00943605 on ClinicalTrials.gov