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Use of the PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction

NCT01404351 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2013-01-07

No results posted yet for this study

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 to compare these outcomes to the HARMONIC SYNERGY® BLADE.

Conditions

  • Macromastia (Symptomatic)

Interventions

DEVICE

PEAK PlasmaBlade

PROCEDURE

Scalpel and Traditional Electrosurgery

Sponsors & Collaborators

  • Medtronic Surgical Technologies

    lead INDUSTRY

Principal Investigators

  • Denis Gonyon, MD · Gonyon Cosmetic & Plastic Surgery, PC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2011-10-31
Completion
2011-11-30

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 NCT01404351 on ClinicalTrials.gov