Macromastia Clinical Trial
Official title:
A Prospective, Randomized, Controlled Study to Evaluate Use of the PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction
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).
Bilateral breast reduction is a surgical procedure performed to remove excess breast tissue
from both female breasts for therapeutic or cosmetic indications. The purpose of the breast
reduction is to decrease the weight of the breasts and restructure the breast tissue for a
more favorable appearance. Typically, a scalpel is used for the skin incision and a
traditional electrosurgical device is used to cut away any excess tissue.
The PEAK PlasmaBladeā¢ uses pulsed radiofrequency (RF) energy and a highly-insulated
handpiece design to enable precision cutting and coagulation at the point of application.
The PlasmaBlade has received FDA clearance for use in plastic, general, and ear, nose, and
throat (ENT) surgery, and has demonstrated a significantly reduced thermal injury profile in
incised tissue compared to traditional electrosurgical devices. It is hypothesized that this
benefit may improve the post-operative outcome of patients undergoing bilateral breast
reduction.
A total of forty-five (45) subjects were enrolled into the study. Forty-three (43) underwent
bilateral breast reduction, and two (2) subjects were withdrawn prior to surgery. Enrollment
and surgeries took place between 18 September 2009 and 12 August 2011. Potential subjects
were screened against the inclusion and exclusion criteria of the study protocol and were
required to provide informed consent prior to enrollment. Following enrollment, subject
operative sites were prospectively randomized to the SOC or PlasmaBlade (PB or PEAK) study
groups and scheduled for bilateral breast reduction. Subjects were unaware of which device
was used on which breast. Subjects were required to attend two follow-up visits after
surgery, approximately one and six weeks following surgery.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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