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

Primary Purpose

Tonsillitis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PEAK PlasmaBlade TnA
Traditional Electrosurgery with scalpel
Sponsored by
Medtronic Surgical Technologies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tonsillitis focused on measuring Tonsillectomy, PlasmaBlade, Electrosurgery, PEAK Surgical, Medtronic Advanced Energy, Medtronic

Eligibility Criteria

3 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Surgery Center Merced
  • Alvarado Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of Care

PlasmaBlade

Arm Description

Traditional electrosurgery will be used for the tonsillectomy.

The PEAK PlasmaBlade will be used for the tonsillectomy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Operative Time, Estimated Blood Loss (EBL), Diet Volume and Activity Level

Full Information

First Posted
August 31, 2010
Last Updated
November 29, 2012
Sponsor
Medtronic Surgical Technologies
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1. Study Identification

Unique Protocol Identification Number
NCT01193556
Brief Title
PEAK PlasmaBlade TnA Versus Traditional Electrosurgery in Subcapsular Tonsillectomy
Acronym
PRECISE
Official Title
A Prospective, Randomized, Double-blinded, Controlled Study to Evaluate Use of the PEAK PlasmaBlade TnA in Subcapsular Tonsillectomy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Terminated
Why Stopped
Termination due to acquisition of PEAK Surgical by Medtronic
Study Start Date
July 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Surgical Technologies

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tonsillitis
Keywords
Tonsillectomy, PlasmaBlade, Electrosurgery, PEAK Surgical, Medtronic Advanced Energy, Medtronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Traditional electrosurgery will be used for the tonsillectomy.
Arm Title
PlasmaBlade
Arm Type
Experimental
Arm Description
The PEAK PlasmaBlade will be used for the tonsillectomy.
Intervention Type
Device
Intervention Name(s)
PEAK PlasmaBlade TnA
Other Intervention Name(s)
PEAK, PlasmaBlade, Plasma Blade, TnA, Tonsil and Adenoid
Intervention Description
The PEAK PlasmaBlade will be used for the tonsillectomy.
Intervention Type
Device
Intervention Name(s)
Traditional Electrosurgery with scalpel
Other Intervention Name(s)
Electrosurgery, Electrocautery, Bovie
Intervention Description
Traditional electrosurgery for the tonsillectomy.
Primary Outcome Measure Information:
Title
Post-operative Pain
Description
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.
Time Frame
10 days immediately following surgery
Secondary Outcome Measure Information:
Title
Operative Time, Estimated Blood Loss (EBL), Diet Volume and Activity Level
Time Frame
1-2 weeks post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children & adolescents: Age 3-17; Adults: 18 and older Physically healthy, stable weight Requiring tonsillectomy and adenoidectomy per widely accepted indications For adults, subject must understand the nature of the procedure and provide written informed consent. 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. For children under 7 years old, parent or guardian must understand the nature of the procedure and provide written informed consent. 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: Children: Age 2 and under Bleeding disorder Peritonsillar abscess Requiring concomitant uvulopalatopharyngoplasty (UPPP) Anticoagulation therapy which cannot be discontinued Unable to follow instructions or complete follow-up Currently taking any medication known to affect healing Currently enrolled in another investigational device or drug trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Weeks, MD
Organizational Affiliation
Senta Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Spitzer, DO
Organizational Affiliation
Mark Spitzer, DO
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Surgery Center Merced
City
Merced
State/Province
California
ZIP/Postal Code
95340
Country
United States
Facility Name
Alvarado Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States

12. IPD Sharing Statement

Learn more about this trial

PEAK PlasmaBlade TnA Versus Traditional Electrosurgery in Subcapsular Tonsillectomy

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