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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This study has been withdrawn prior to enrollment.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

July 25, 2011
January 3, 2013
May 2011
October 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01404351 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Macromastia (Symptomatic)
  • Device: PEAK PlasmaBlade
  • Procedure: Scalpel and Traditional Electrosurgery
  • Experimental: PEAK PlasmaBlade
    Intervention: 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.
    Intervention: Procedure: Scalpel and Traditional Electrosurgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
November 2011
October 2011   (final data collection date for primary outcome measure)

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
Female
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01404351
VP-00133
No
Medtronic Surgical Technologies
Medtronic Surgical Technologies
Not Provided
Principal Investigator: Denis Gonyon, MD Gonyon Cosmetic & Plastic Surgery, PC
Medtronic Surgical Technologies
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP