PEAK PlasmaBlade TnA Versus Traditional Electrosurgery in Subcapsular Tonsillectomy

Not Applicable

Terminated

• Conditions: Tonsillitis
• Interventions: Device: Traditional Electrosurgery with scalpel; Device: PEAK PlasmaBlade TnA

• Registration Number: NCT01193556
• Lead Sponsor: 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).

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 Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-08-31
• Study First Submitted QC: 2010-09-01
• Study First Posted: 2010-09-02
• Primary Completion: 2012-03
• Study Completion: 2012-04
• Status Verified: 2012-11
• Results First Submitted: 2012-11-29
• Results First Submitted QC: 2012-11-29
• Last Update Submitted: 2012-11-29
• Results First Posted: 2013-01-03
• Last Update Posted: 2013-01-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 51

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	Traditional Electrosurgery with scalpel	Traditional electrosurgery will be used for the tonsillectomy.
PlasmaBlade	PEAK PlasmaBlade TnA	The PEAK PlasmaBlade will be used for the tonsillectomy.

Primary Outcome Measures

Name	Time	Method
Post-operative Pain	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

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

Trial Locations

Locations (2)

Alvarado Hospital; 🇺🇸 San Diego, California, United States

University Surgery Center Merced; 🇺🇸 Merced, California, United States