PEAK PlasmaBlade TnA Versus Traditional Electrosurgery in Subcapsular Tonsillectomy

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Tonsillitis

Intervention / Treatment
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* Device: PEAK PlasmaBlade TnA
* Device: Traditional Electrosurgery with scalpel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care<br>Traditional electrosurgery will be used for the tonsillectomy. | Device: Traditional Electrosurgery with scalpel<br>* Traditional electrosurgery for the tonsillectomy.<br>* Other names: Bovie;|
| Experimental: PlasmaBlade<br>The PEAK PlasmaBlade will be used for the tonsillectomy. | Device: PEAK PlasmaBlade TnA<br>* The PEAK PlasmaBlade will be used for the tonsillectomy.<br>* Other names: Tonsil and Adenoid;|

What is the study measuring?
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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 | Measure Description | Time Frame |
| --- | --- | --- |
| Operative Time, Estimated Blood Loss (EBL), Diet Volume and Activity Level |  | 1-2 weeks post-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tonsillectomy, PlasmaBlade, Electrosurgery, PEAK Surgical, Medtronic Advanced Energy, Medtronic