NCT01193556

PEAK PlasmaBlade TnA Versus Traditional Electrosurgery in Subcapsular Tonsillectomy

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Medtronic Surgical Technologies · Industry
• Sex: All
• Age: 3 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Tonsillitis

Interventions

Type	Name	Description
DEVICE	PEAK PlasmaBlade TnA	The PEAK PlasmaBlade will be used for the tonsillectomy.
DEVICE	Traditional Electrosurgery with scalpel	Traditional electrosurgery for the tonsillectomy.

Timeline

• Start date: 2010-07-01
• Primary completion: 2012-03-01
• Completion: 2012-04-01
• First posted: 2010-09-02
• Last updated: 2013-01-03
• Results posted: 2013-01-03

Locations

2 sites across 1 country: United States