Status:
UNKNOWN
Megadyne Ace Incision/Dissection Study
Lead Sponsor:
Megadyne Medical Products Inc.
Conditions:
Abdominoplasty
Bilateral Breast Reduction
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT01175889
Start Date
August 1 2010
End Date
December 1 2012
Last Update
October 25 2012
Active Locations (3)
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1
Center for Plastic Surgery
Twin Falls, Idaho, United States, 83301
2
Southwest Surgical Suites, LLC
Fort Wayne, Indiana, United States, 46804
3
Plastic and Reconstructive Surgery University Health Sciences
Winston-Salem, North Carolina, United States, 27157