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


Clinical Trial Description

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 Forty-three (43) underwent bilateral breast reduction, and two (2) subjects were withdrawn prior to surgery.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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00986453
Study type Interventional
Source Medtronic Surgical Technologies
Contact
Status Completed
Phase N/A
Start date January 2010
Completion date September 2011

See also
  Status Clinical Trial Phase
Completed NCT05288530 - Satisfaction, Pain and Function Outcomes of Breast Reduction Patients
Terminated NCT01284491 - A Study to Evaluate Cutaneous Scar Quality Following Bilateral Breast Reduction With the PEAK PlasmaBlade 4.0 N/A
Completed NCT02769559 - Reduction Mammaplasty and Improved Quality of Life N/A
Terminated NCT02016677 - An Observational Study Exploring the Esthetic Outcomes of Breast Reduction Surgery and /or Mastopexy N/A
Completed NCT00558246 - Study of Prineo (Dermabond Protape) Versus Sutures in Breast Procedures Phase 4
Recruiting NCT05898087 - Subpectoral Bupivacaine for Pain Management in Adolescent Reduction Mammaplasty Phase 4