Use of the PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction

A Prospective, Randomized, Controlled Superiority 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 to compare these outcomes to the HARMONIC SYNERGY® BLADE.

Study Overview

• Status: Withdrawn
• Conditions: Macromastia (Symptomatic)
• Intervention / Treatment: Device: PEAK PlasmaBlade; Procedure: Scalpel and Traditional Electrosurgery

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Johnstown, Colorado, United States, 80534
      • Gonyon Cosmetic & Plastic Surgery, PC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Age between 18 and 70
2. Physically healthy, stable weight
3. No smoking <1 month prior to surgery and during study.
4. Desiring bilateral breast reduction
5. Subject must understand the nature of the procedure and provide written informed consent prior to the procedure.
6. Subject must be willing and able to comply with specified follow-up evaluations.
7. 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 Criteria:

1. Age younger than 18 or greater than 70 years old
2. Anticoagulation therapy which cannot be discontinued
3. Smoking <1 month prior to surgery or during study
4. Infection (local or systemic)
5. Cognitive impairment or mental illness
6. Severe cardiopulmonary deficiencies
7. Known coagulopathy
8. Immunocompromised
9. Prior history of breast cancer
10. Kidney disease (any type)
11. Currently taking any medication known to affect healing
12. Subjects who are status-post gastric banding or gastric bypass
13. Currently enrolled in another investigational device or drug trial
14. Unable to follow instructions or complete follow-up

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PEAK PlasmaBlade	Device: PEAK PlasmaBlade
ACTIVE_COMPARATOR: Standard of Care; The Standard of Care arm will consist of the scalpel for the skin incision and traditional electrosurgery for subcutaneous dissection.	Procedure: Scalpel and Traditional Electrosurgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in pain	The primary endpoint will be the difference in pain between the Harmonic and PlasmaBlade operative sites. The primary efficacy variable will be pain at each treatment arm operative site, as measured by visual analog scale for 24 hours post-operatively and for 10 post-op days twice daily.	24 hours and first 10 days post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative performance	Dissection time (normalized), estimated blood loss, use of traditional device for bleeding control, volume of tissue resection.	Intraoperatively on day 0
Adverse events	Monitoring for adverse events following surgery, including hematoma, seroma, wound dehiscence, etc.	1 month post-operatively
Cutaneous scarring	Scar width, quality, pigmentation, elevation, nodularity, thickness, and cosmetic appearance will be blindly evaluated by subject and independent observers.	Up to one year post-operatively

Collaborators and Investigators

• Sponsor: Medtronic Surgical Technologies
• Investigators: Principal Investigator: Denis Gonyon, MD, Gonyon Cosmetic & Plastic Surgery, PC

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (ACTUAL): October 1, 2011
• Study Completion (ACTUAL): November 1, 2011

Study Registration Dates

• First Submitted: July 25, 2011
• First Submitted That Met QC Criteria: July 27, 2011
• First Posted (ESTIMATE): July 28, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): January 7, 2013
• Last Update Submitted That Met QC Criteria: January 3, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Breast reduction; PlasmaBlade; Reduction mammaplasty; PEAK
• Other Study ID Numbers: VP-00133