Use of the PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction

Withdrawn before enrolling · Not applicable

Conditions studied: Macromastia (Symptomatic)

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 to compare these outcomes to the HARMONIC SYNERGY® BLADE.

Key facts

Study ID

NCT01404351

Run by

Medtronic Surgical Technologies

People needed

0

Starts

2011-05-01

Expected to finish

2011-11-01

Last updated by the study team

2013-01-07

Who can join

Age: 18 and older, up to 70. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Gonyon Cosmetic & Plastic Surgery, PC — Johnstown, Colorado, United States

Full record on ClinicalTrials.gov

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