PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction

Completed · Not applicable

Conditions studied: Macromastia

In brief

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 and skin scarring following surgery; and compare these outcomes to the current standard of care (SOC).

Key facts

Study ID

NCT00986453

Run by

Medtronic Surgical Technologies

People needed

45

Starts

2010-01-01

Expected to finish

2011-09-01

Last updated by the study team

2013-01-01

Who can join

Age: 20 and older, up to 60. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Age between 20 and 60
• Physically healthy, stable weight, non-smoker
• 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 no longer capable of reproduction, or taking acceptable measures to prevent pregnancy during the study, and have a negative pregnancy test prior to participation in the study.

You may not qualify if…

• Age younger than 20 or greater than 60 years old
• Anticoagulation therapy which cannot be discontinued
• Smoking (any kind)
• 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

Where it is running

• Providence St. Joseph's — Burbank, California, United States
• Verdugo Hills Hospital — Glendale, California, United States
• El Camino Hospital — Mountain View, California, United States
• Tri-City Medical Center — Oceanside, California, United States
• Sharp Outpatient Pavilion — San Diego, California, United States
• Rancho Bernardo Surgery Center — San Diego, California, United States
• University Hospitals — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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