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Trial record 2 of 5 for:    "Gigantomastia"
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PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction (PRECISE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Surgical Technologies
ClinicalTrials.gov Identifier:
NCT00986453
First received: September 28, 2009
Last updated: November 29, 2012
Last verified: November 2012
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 compare these outcomes to the current standard of care (SOC).


Condition Intervention
Macromastia
 Device: PEAK PlasmaBlade
Procedure: Traditional Electrosurgery with scalpel

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled 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:
  • Postoperative Pain [ Time Frame: 0 to 10 days postoperative ] [ Designated as safety issue: No ]

    The difference in pain was measured by visual analog scale for 24 hours post-operatively and for 10 post-operative days twice daily between the SOC and PlasmaBlade operative sites.

    Wong-Baker FACES Visual Analog Scale, 0 (no hurt) to 10 (hurts worst). The results represent the mean of each subject's mean pain scores over 10 days.



Secondary Outcome Measures:
  • Estimated Blood Loss [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
  • Operative Time [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
  • Amount of Tissue Removed [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
  • Dissection Performance [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
    Amount of tissue (g) removed over time (min)


Enrollment: 45
Study Start Date: January 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PlasmaBlade arm
The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.
 Device: PEAK PlasmaBlade
The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.
Other Name: PlasmaBlade
Active Comparator: Standard of Care
Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
 Procedure: Traditional Electrosurgery with scalpel
Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
Other Names:
  • Scalpel
  • Electrosurgery
  • SOC

Detailed 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 PlasmaBlade™ 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.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age between 20 and 60
  2. Physically healthy, stable weight, non-smoker
  3. Desiring bilateral breast reduction
  4. Subject must understand the nature of the procedure and provide written informed consent prior to the procedure.
  5. Subject must be willing and able to comply with specified follow-up evaluations.
  6. Female subjects must either be no longer capable of reproduction, or taking acceptable measures to prevent pregnancy during the study, and have a negative pregnancy test prior to participation in the study.

Exclusion Criteria:

  1. Age younger than 20 or greater than 60 years old
  2. Anticoagulation therapy which cannot be discontinued
  3. Smoking (any kind)
  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: NCT00986453

Locations
United States, California
Providence St. Joseph's
Burbank, California, United States, 91505
Verdugo Hills Hospital
Glendale, California, United States, 91218
El Camino Hospital
Mountain View, California, United States, 94040
Tri-City Medical Center
Oceanside, California, United States, 92056
Sharp Outpatient Pavilion
San Diego, California, United States, 92123
Rancho Bernardo Surgery Center
San Diego, California, United States, 92128
United States, Ohio
University Hospitals
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Medtronic Surgical Technologies
Investigators
Principal Investigator: Abhay Gupta, MD Gupta Plastic Surgery
Principal Investigator: Howard Rosenberg, MD Accent on Aesthetics Plastic Surgery
Principal Investigator: Susan Downey, MD Susan Downey, MD, FACS
Principal Investigator: Larry Pollack, MD Del Mar Plastic Surgery
Principal Investigator: Hooman Soltanian, MD University Hospital Cleveland
  More Information

No publications provided

Responsible Party: Medtronic Surgical Technologies
ClinicalTrials.gov Identifier: NCT00986453     History of Changes
Other Study ID Numbers: PEAK VP-00065
Study First Received: September 28, 2009
Results First Received: November 29, 2012
Last Updated: November 29, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Medtronic Surgical Technologies:
Breast Reduction
PlasmaBlade
Electrosurgery
 PEAK Surgical
Medtronic Advanced Energy
Medtronic

ClinicalTrials.gov processed this record on May 19, 2013