CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 45 enrolled
Drug / intervention
PEAK PlasmaBlade +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00986453
NCT00986453N/ACompleted
CompareCT.gov

A Prospective, Randomized, Controlled Study to Evaluate Use of the PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction

Medtronic Surgical Technologies·interventional·Posted Sep 30, 2009·Updated Jan 1, 2013

In Brief

A clinical study evaluating PEAK PlasmaBlade and Traditional Electrosurgery with scalpel for Macromastia. Completed, enrolled 45 participants across 7 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMacromastia
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 30, 2009
Enrollment StartJan 1, 2010
Primary CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 16.8 years ago

Interventions

PEAK PlasmaBladedevice

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

Traditional Electrosurgery with scalpelprocedure

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