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PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction

NCT00986453 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2013-01-01

Study results available
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Summary

The objective of this clinical study is to evaluate the operative performance of the PEAK PlasmaBlade 4.0 during bilateral breast reduction; to monitor and record post-operative pain, adverse events and skin scarring following surgery; and compare these outcomes to the current standard of care (SOC).

Conditions

  • Macromastia

Interventions

DEVICE

PEAK PlasmaBlade

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

PROCEDURE

Traditional Electrosurgery with scalpel

Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.

Sponsors & Collaborators

  • Medtronic Surgical Technologies

    lead INDUSTRY

Principal Investigators

  • Abhay Gupta, MD · Gupta Plastic Surgery

  • Howard Rosenberg, MD · Accent on Aesthetics Plastic Surgery

  • Susan Downey, MD · Susan Downey, MD, FACS

  • Larry Pollack, MD · Del Mar Plastic Surgery

  • Hooman Soltanian, MD · University Hospital Cleveland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2011-09-30
Completion
2011-09-30

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 NCT00986453 on ClinicalTrials.gov