PEAK PlasmaBlade TnA Versus Traditional Electrosurgery in Subcapsular Tonsillectomy (PRECISE)

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: NCT01193556
Recruitment Status : Terminated (Termination due to acquisition of PEAK Surgical by Medtronic)
First Posted : September 2, 2010
Results First Posted : January 3, 2013
Last Update Posted : January 3, 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® TnA during subcapsular tonsillectomy; to monitor and record post-operative clinical outcome variables; and to compare these endpoints to the Standard of Care (SOC).

Condition or disease Intervention/treatment Phase
Tonsillitis Device: PEAK PlasmaBlade TnA Device: Traditional Electrosurgery with scalpel Not Applicable

Detailed Description:

Tonsillectomy is performed in response to cases of repeated occurrence of acute tonsillitis or adenoiditis, obstructive sleep apnea, nasal airway obstruction, snoring, or peritonsillar abscess.

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, orthopedic, 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 tonsillectomy.

Two study sites were granted approval for this prospective randomized study. Potential subjects were screened against the inclusion and exclusion criteria of the study protocol and were required to provide informed consent for themselves (adults) or for their child prior to enrollment. Following enrollment, subjects were prospectively randomized to the SOC or PlasmaBlade (PB or PEAK) study groups and scheduled for tonsillectomy or tonsillectomy and adenoidectomy (TnA).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double-blinded, Controlled Study to Evaluate Use of the PEAK PlasmaBlade TnA in Subcapsular Tonsillectomy
Study Start Date : July 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tonsillitis

Arm Intervention/treatment
Active Comparator: Standard of Care
Traditional electrosurgery will be used for the tonsillectomy.
Device: Traditional Electrosurgery with scalpel
Traditional electrosurgery for the tonsillectomy.
Other Names:
  • Electrosurgery
  • Electrocautery
  • Bovie

Experimental: PlasmaBlade
The PEAK PlasmaBlade will be used for the tonsillectomy.
Device: PEAK PlasmaBlade TnA
The PEAK PlasmaBlade will be used for the tonsillectomy.
Other Names:
  • PEAK
  • PlasmaBlade
  • Plasma Blade
  • TnA
  • Tonsil and Adenoid

Primary Outcome Measures :
  1. Post-operative Pain [ Time Frame: 10 days immediately following surgery ]
    The primary outcome measure will be pain in each treatment group, as measured by visual analog scale twice daily in the 10 day period directly following surgery.

Secondary Outcome Measures :
  1. Operative Time, Estimated Blood Loss (EBL), Diet Volume and Activity Level [ Time Frame: 1-2 weeks post-operatively ]

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Children & adolescents: Age 3-17; Adults: 18 and older
  2. Physically healthy, stable weight
  3. Requiring tonsillectomy and adenoidectomy per widely accepted indications
  4. For adults, subject must understand the nature of the procedure and provide written informed consent.
  5. For children and adolescents age 7 to 17, subject must understand the nature of the procedure and be able to give verbal assent prior to the procedure. In addition, parent or guardian must provide written informed consent.
  6. For children under 7 years old, parent or guardian must understand the nature of the procedure and provide written informed consent.
  7. Subject (or responsible parent or guardian) must be willing and able to comply with all follow-up evaluations, including completion of study data sheets.

Exclusion Criteria:

  1. Children: Age 2 and under
  2. Bleeding disorder
  3. Peritonsillar abscess
  4. Requiring concomitant uvulopalatopharyngoplasty (UPPP)
  5. Anticoagulation therapy which cannot be discontinued
  6. Unable to follow instructions or complete follow-up
  7. Currently taking any medication known to affect healing
  8. Currently enrolled in another investigational device or drug trial

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): NCT01193556

United States, California
University Surgery Center Merced
Merced, California, United States, 95340
Alvarado Hospital
San Diego, California, United States, 92120
Sponsors and Collaborators
Medtronic Surgical Technologies
Principal Investigator: Brian Weeks, MD Senta Clinic
Principal Investigator: Mark Spitzer, DO Mark Spitzer, DO

Responsible Party: Medtronic Surgical Technologies Identifier: NCT01193556     History of Changes
Other Study ID Numbers: PEAK VP-00075
First Posted: September 2, 2010    Key Record Dates
Results First Posted: January 3, 2013
Last Update Posted: January 3, 2013
Last Verified: November 2012

Keywords provided by Medtronic Surgical Technologies:
PEAK Surgical
Medtronic Advanced Energy

Additional relevant MeSH terms:
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases