Text Size

Use of the PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction

This study has been withdrawn prior to enrollment.
(Study terminated due to the acquisition of PEAK Surgical by Medtronic)
Sponsor:
Information provided by (Responsible Party):
Medtronic Surgical Technologies
ClinicalTrials.gov Identifier:
NCT01404351
First received: July 25, 2011
Last updated: January 3, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention
Macromastia (Symptomatic)
 Device: PEAK PlasmaBlade
Procedure: Scalpel and Traditional Electrosurgery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled Superiority Study to Evaluate Use of the PEAK PlasmaBlade® 4.0 in Bilateral Breast Reduction

Further study details as provided by Medtronic Surgical Technologies:

Primary Outcome Measures:
  • Difference in pain [ Time Frame: 24 hours and first 10 days post-op ] [ Designated as safety issue: No ]
    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:
  • Operative performance [ Time Frame: Intraoperatively on day 0 ] [ Designated as safety issue: No ]
    Dissection time (normalized), estimated blood loss, use of traditional device for bleeding control, volume of tissue resection.

  • Adverse events [ Time Frame: 1 month post-operatively ] [ Designated as safety issue: Yes ]
    Monitoring for adverse events following surgery, including hematoma, seroma, wound dehiscence, etc.

  • Cutaneous scarring [ Time Frame: Up to one year post-operatively ] [ Designated as safety issue: No ]
    Scar width, quality, pigmentation, elevation, nodularity, thickness, and cosmetic appearance will be blindly evaluated by subject and independent observers.


Enrollment: 0
Study Start Date: May 2011
Study Completion Date: November 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01404351

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

No publications provided

Responsible Party: Medtronic Surgical Technologies
ClinicalTrials.gov Identifier: NCT01404351     History of Changes
Other Study ID Numbers: VP-00133
Study First Received: July 25, 2011
Last Updated: January 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Surgical Technologies:
Reduction mammaplasty
Breast reduction
PlasmaBlade
PEAK

ClinicalTrials.gov processed this record on June 17, 2013