Megadyne Ace Incision/Dissection Study

NCT ID: NCT01175889

Last Updated: 2012-10-25

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2012-12-31

Brief Summary

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The Megadyne Ace™ Incision/ Dissection study is a post market, 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.

Detailed Description

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Conditions

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Abdominoplasty Bilateral Breast Reduction Bilateral Breast Lift Bilateral Brachioplasty Bilateral Lateral Thigh and Buttocks Lift

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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one side ACE blade

Group Type EXPERIMENTAL

E-Z Clean ACE Blade

Intervention Type DEVICE

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

Group Type ACTIVE_COMPARATOR

E-Z Clean ACE Blade

Intervention Type DEVICE

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.

Intervention Type DEVICE

Other Intervention Names

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ACE Blade

Eligibility Criteria

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Inclusion Criteria

* Subject is \>18 years of age or \< 60 years old
* 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 smoking in the last 6 months prior to surgery.
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Megadyne Medical Products Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Southwest Surgical Suites, LLC

Fort Wayne, Indiana, United States

Site Status

Plastic and Reconstructive Surgery University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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ACE MS 1

Identifier Type: -

Identifier Source: org_study_id