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

This study has been terminated.
(Termination due to acquisition of PEAK Surgical by Medtronic)
Sponsor:
Information provided by (Responsible Party):
Medtronic Surgical Technologies
ClinicalTrials.gov Identifier:
NCT01193556
First received: August 31, 2010
Last updated: November 29, 2012
Last verified: November 2012
  Purpose

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 Intervention
Tonsillitis
Device: PEAK PlasmaBlade TnA
Device: Traditional Electrosurgery with scalpel

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double-blinded, Controlled Study to Evaluate Use of the PEAK PlasmaBlade TnA in Subcapsular Tonsillectomy

Resource links provided by NLM:


Further study details as provided by Medtronic Surgical Technologies:

Primary Outcome Measures:
  • Post-operative Pain [ Time Frame: 10 days immediately following surgery ] [ Designated as safety issue: No ]
    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:
  • Operative Time, Estimated Blood Loss (EBL), Diet Volume and Activity Level [ Time Frame: 1-2 weeks post-operatively ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: July 2010
Study Completion Date: April 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   3 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01193556

Locations
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
Investigators
Principal Investigator: Brian Weeks, MD Senta Clinic
Principal Investigator: Mark Spitzer, DO Mark Spitzer, DO
  More Information

No publications provided

Responsible Party: Medtronic Surgical Technologies
ClinicalTrials.gov Identifier: NCT01193556     History of Changes
Other Study ID Numbers: PEAK VP-00075
Study First Received: August 31, 2010
Results First Received: November 29, 2012
Last Updated: November 29, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 14, 2014