Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
52 participants
INTERVENTIONAL
2010-08-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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one side ACE blade
E-Z Clean ACE Blade
The prospective assessment of the E-Z Clean ACE electrosurgical electrodes using the ACE Blade in the ACE Mode for targeted procedures such as abdominoplasty, bilateral breast reduction, bilateral breast lifts, bilateral brachioplasty, bilateral lateral thigh and buttocks lifts, or any combination thereof.
one side scalpel
E-Z Clean ACE Blade
The prospective assessment of the E-Z Clean ACE electrosurgical electrodes using the ACE Blade in the ACE Mode for targeted procedures such as abdominoplasty, bilateral breast reduction, bilateral breast lifts, bilateral brachioplasty, bilateral lateral thigh and buttocks lifts, or any combination thereof.
Interventions
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E-Z Clean ACE Blade
The prospective assessment of the E-Z Clean ACE electrosurgical electrodes using the ACE Blade in the ACE Mode for targeted procedures such as abdominoplasty, bilateral breast reduction, bilateral breast lifts, bilateral brachioplasty, bilateral lateral thigh and buttocks lifts, or any combination thereof.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject is undergoing abdominoplasty, bilateral breast reduction, bilateral breast lift, bilateral brachioplasty, bilateral lateral thigh and buttocks lift, or any combination thereof
* Subject is able to discontinue anticoagulant therapy (including Aspirin)
* Subject is willing and able to comply with study follow-up procedures
* Subject is willing to provide written informed consent for their participation in the study
Exclusion Criteria
* Subject has a history of type I or type II Diabetes.
* Subject has an active infection of any kind at the time of enrollment
* Subject has a known coagulopathy
18 Years
60 Years
ALL
No
Sponsors
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Megadyne Medical Products Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Ryan D Lewis, M.D.
Role: STUDY_CHAIR
Sponsor GmbH
Locations
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Center for Plastic Surgery
Twin Falls, Idaho, United States
Southwest Surgical Suites, LLC
Fort Wayne, Indiana, United States
Plastic and Reconstructive Surgery University Health Sciences
Winston-Salem, North Carolina, United States
Countries
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Other Identifiers
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ACE MS 1
Identifier Type: -
Identifier Source: org_study_id