CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 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/NCT00943150
NCT00943150N/ACompleted
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A Prospective, Randomized, Controlled Two-arm Superiority Study to Evaluate Use of the PEAK PlasmaBlade™ 4.0 in Abdominoplasty

Medtronic Surgical Technologies·interventional·Posted Jul 22, 2009·Updated Jan 1, 2013

In Brief

A clinical study evaluating PEAK PlasmaBlade and Standard of Care (SOC) for Elastosis. Completed, enrolled 20 participants across 1 site.

Detailed Summary

The objective of this clinical study is to evaluate healing of incisions made with the PEAK PlasmaBlade 4.0 compared to scalpel and traditional electrosurgery (Bovie); to monitor and record key post-operative metrics following abdominoplasty with the PEAK PlasmaBlade 4.0 versus current standard of care (SOC); and to evaluate performance metrics of the PEAK PlasmaBlade 4.0 during abdominoplasty.

Study Details

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

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 22, 2009
Enrollment StartDec 1, 2008
Primary CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 16.9 years ago

Interventions

PEAK PlasmaBladedevice

The PEAK PlasmaBlade will be used for the abdominoplasty procedure.

Standard of Care (SOC)procedure

The scalpel and electrocautery will be used for the abdominoplasty procedure.