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

A Prospective, Randomized, Double-blinded, Controlled Study to Evaluate Use of the PEAK PlasmaBlade TnA in Subcapsular Tonsillectomy

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).

Study Overview

• Status: Terminated
• Conditions: Tonsillitis
• Intervention / Treatment: Device: Traditional Electrosurgery with scalpel; Device: PEAK PlasmaBlade TnA

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
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Merced, California, United States, 95340
      • University Surgery Center Merced
    • San Diego, California, United States, 92120
      • Alvarado Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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: Bovie; Electrosurgery; Electrocautery
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: PlasmaBlade; PEAK; Plasma Blade; TnA; Tonsil and Adenoid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative Pain	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.	10 days immediately following surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Operative Time, Estimated Blood Loss (EBL), Diet Volume and Activity Level	1-2 weeks post-operatively

Collaborators and Investigators

• Sponsor: Medtronic Surgical Technologies
• Investigators: Principal Investigator: Brian Weeks, MD, Senta Clinic; Principal Investigator: Mark Spitzer, DO, Mark Spitzer, DO

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: August 31, 2010
• First Submitted That Met QC Criteria: September 1, 2010
• First Posted (Estimate): September 2, 2010

Study Record Updates

• Last Update Posted (Estimate): January 3, 2013
• Last Update Submitted That Met QC Criteria: November 29, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Tonsillectomy; PlasmaBlade; Electrosurgery; PEAK Surgical; Medtronic Advanced Energy; Medtronic
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Pharyngitis; Tonsillitis
• Other Study ID Numbers: PEAK VP-00075