Megadyne Ace Incision/Dissection Study

Status unconfirmed · Phase 4

Conditions studied: Abdominoplasty, Bilateral Breast Reduction, Bilateral Breast Lift, Bilateral Brachioplasty, Bilateral Lateral Thigh and Buttocks Lift

In brief

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.

Key facts

Study ID

NCT01175889

Run by

Megadyne Medical Products Inc.

People needed

52

Starts

2010-08-01

Expected to finish

2012-12-01

Last updated by the study team

2012-10-25

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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