Clinical trial NCT01193556: PEAK PlasmaBlade TnA Versus Traditional Electrosurgery in Subcapsular Tonsillectomy
Official title: A Prospective, Randomized, Double-blinded, Controlled Study to Evaluate Use of the PEAK PlasmaBlade TnA in Subcapsular Tonsillectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Tonsillitis
Keywords: Tonsillectomy
PlasmaBlade
Electrosurgery
PEAK Surgical
Medtronic Advanced Energy
Medtronic
Lead sponsor: Medtronic Surgical Technologies
Sponsor class: INDUSTRY
First posted: 2010-09-02
Enrollment: 51
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Post-operative Pain
timeFrame: 10 days immediately following surgery
Secondary outcomes:
measure: Operative Time, Estimated Blood Loss (EBL), Diet Volume and Activity Level
timeFrame: 1-2 weeks post-operatively
Other outcomes:
Locations:
city: Merced
country: United States
facility: University Surgery Center Merced
state: California
city: San Diego
country: United States
facility: Alvarado Hospital
state: California
Study officials:
affiliation: Senta Clinic
name: Brian Weeks, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mark Spitzer, DO
name: Mark Spitzer, DO
role: PRINCIPAL_INVESTIGATOR
References: