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"We have been impressed with the reduced tissue charring and the ability to work close to delicate and sensitive tissues with the PlasmaBlade, which is especially important in gynecologic procedures in which the bowel, ureter and ovaries are close by."
— Dr. Fermin F. Barrueto, chief of endoscopy and pelvic reconstruction at Mercy Medical Center in Baltimore.

PRECISE Studies

Preclinical research has demonstrated that the PEAK PlasmaBlade offers a significantly improved wound healing and thermal injury profile compared to traditional electrosurgery. In order to examine post-operative outcomes in patients treated with the PlasmaBlade, PEAK Surgical has initiated a series of clinical trials -- the PRECISE Studies (Pulsed Plasma Radiofrequency Energy to ReduCe Thermal Injury and Improve Surgical HEaling). These studies are currently underway in plastic, reconstructive, gynecologic and oncologic surgery.

Plastic Surgery Studies
  • Abdominoplasty (“tummy tuck”)
    • Randomized controlled clinical trial (RCT) of 20 patients
    • ClinicalTrials.gov Identifier: NCT00943150
    • PlasmaBlade subjects demonstrated significantly improved narcotic consumption & pain scores, return to normal activity and diet, and less blood loss compared to scalpel and traditional electrosurgery.
    • Results accepted for podium presentation at the American College of Surgeons and European Society of Plastic, Reconstructive and Aesthetic Surgery 2009 annual meetings.

Breast Oncology Studies

  • Mastectomy
    • Randomized controlled clinical trial (RCT) of 60 patients
    • Examining wound drainage, operative performance, blood loss, pain & narcotic consumption, and return to activity following simple mastectomy
    • Kennestone Hospital, Atlanta, GA; Nix Medical Center, San Antonio, TX; Providence St. Joseph's Medical Center, Burbank, CA; El Camino Hospital, Mountain View, CA; Elliot Hospital, Manchester, NH.
    • ClinicalTrials.gov Identifier: NCT00943605

  • Lumpectomy
    • Randomized controlled clinical trial (RCT) of 60 patients
    • Examining impact of thermal injury on re-excision rates, pathologic analysis and adverse events in malignant breast lump excision
    • El Camino Hospital, Mountain View, CA
    • ClinicalTrials.gov Identifier: NCT00960154
  • Surgical Excision Margins
    • Randomized controlled clinical trial (RCT) of 20 patients
    • Examining thermal injury artifact by intensive pathologic analysis via gross inspection, touch imprint cytology, and permanent histologic analysis
    • University of California, San Diego & Moores UCSD Cancer Center
    • ClinicalTrials.gov Identifier: NCT00972010
Gynecologic Surgery Studies
  • Total abdominal hysterectomy
    • Randomized controlled clinical trial (RCT) of 40 patients
    • Evaluating post-operative narcotic consumption, time to discharge, uterine thermal injury, operative performance, blood loss and adverse events
    • University of Maryland Mercy Medical Center, Baltimore, MD

For more information about the clinical studies, please contact PEAK Surgical's Clinical Research Assistant, Dominique Atmodjo, at datmodjo@peaksurgical.com or the Director of Clinical Affairs, Josh Vose MD, at jvose@peaksurgical.com

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