PEAK PlasmaBlade TnA Versus Traditional Electrosurgery in Subcapsular Tonsillectomy

Tonsillitis Clinical Trial

— PRECISE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01193556
• Other study ID #: PEAK VP-00075
• Status: Terminated
• Phase: N/A
• First received: August 31, 2010
• Last updated: November 29, 2012
• Start date: July 2010
• Est. completion date: April 2012

Study information

• Verified date: November 2012
• Source: Medtronic Surgical Technologies
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 51
• Est. completion date: April 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tonsillitis

Intervention

Device:
• PEAK PlasmaBlade TnA
The PEAK PlasmaBlade will be used for the tonsillectomy.
• Traditional Electrosurgery with scalpel
Traditional electrosurgery for the tonsillectomy.

Locations

Country	Name	City	State
United States	University Surgery Center Merced	Merced	California
United States	Alvarado Hospital	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Surgical Technologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Operative Time, Estimated Blood Loss (EBL), Diet Volume and Activity Level		1-2 weeks post-operatively	No