Use of the PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01404351
Recruitment Status : Withdrawn (Study terminated due to the acquisition of PEAK Surgical by Medtronic)
First Posted : July 28, 2011
Last Update Posted : January 7, 2013
Information provided by (Responsible Party):
Medtronic Surgical Technologies

Brief 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 to compare these outcomes to the HARMONIC SYNERGY® BLADE.

Condition or disease Intervention/treatment Phase
Macromastia (Symptomatic) Device: PEAK PlasmaBlade Procedure: Scalpel and Traditional Electrosurgery Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled Superiority Study to Evaluate Use of the PEAK PlasmaBlade® 4.0 in Bilateral Breast Reduction
Study Start Date : May 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : November 2011

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

Primary Outcome Measures :
  1. Difference in pain [ Time Frame: 24 hours and first 10 days post-op ]
    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.

Secondary Outcome Measures :
  1. Operative performance [ Time Frame: Intraoperatively on day 0 ]
    Dissection time (normalized), estimated blood loss, use of traditional device for bleeding control, volume of tissue resection.

  2. Adverse events [ Time Frame: 1 month post-operatively ]
    Monitoring for adverse events following surgery, including hematoma, seroma, wound dehiscence, etc.

  3. Cutaneous scarring [ Time Frame: Up to one year post-operatively ]
    Scar width, quality, pigmentation, elevation, nodularity, thickness, and cosmetic appearance will be blindly evaluated by subject and independent observers.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01404351

United States, Colorado
Gonyon Cosmetic & Plastic Surgery, PC
Johnstown, Colorado, United States, 80534
Sponsors and Collaborators
Medtronic Surgical Technologies
Principal Investigator: Denis Gonyon, MD Gonyon Cosmetic & Plastic Surgery, PC

Responsible Party: Medtronic Surgical Technologies Identifier: NCT01404351     History of Changes
Other Study ID Numbers: VP-00133
First Posted: July 28, 2011    Key Record Dates
Last Update Posted: January 7, 2013
Last Verified: January 2013

Keywords provided by Medtronic Surgical Technologies:
Reduction mammaplasty
Breast reduction