Status:
WITHDRAWN
Use of the PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction
Lead Sponsor:
Medtronic Surgical Technologies
Conditions:
Macromastia (Symptomatic)
Eligibility:
FEMALE
18-70 years
Phase:
NA
Brief Summary
The objective of this clinical study is to evaluate the operative performance of the PEAK PlasmaBlade® 4.0 during bilateral breast reduction; to monitor and record post-operative pain, adverse events ...
Eligibility Criteria
Inclusion
- Age between 18 and 70
- Physically healthy, stable weight
- No smoking \<1 month prior to surgery and during study.
- Desiring bilateral breast reduction
- Subject must understand the nature of the procedure and provide written informed consent prior to the procedure.
- Subject must be willing and able to comply with specified follow-up evaluations.
- Female subjects must either be incapable of reproduction, or taking acceptable measures to prevent pregnancy and have a negative pregnancy test prior to participation in the study.
Exclusion
- Age younger than 18 or greater than 70 years old
- Anticoagulation therapy which cannot be discontinued
- Smoking \<1 month prior to surgery or during study
- Infection (local or systemic)
- Cognitive impairment or mental illness
- Severe cardiopulmonary deficiencies
- Known coagulopathy
- Immunocompromised
- Prior history of breast cancer
- Kidney disease (any type)
- Currently taking any medication known to affect healing
- Subjects who are status-post gastric banding or gastric bypass
- Currently enrolled in another investigational device or drug trial
- Unable to follow instructions or complete follow-up
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01404351
Start Date
May 1 2011
End Date
November 1 2011
Last Update
January 7 2013
Active Locations (1)
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1
Gonyon Cosmetic & Plastic Surgery, PC
Johnstown, Colorado, United States, 80534