PEAK PlasmaBlade TnA Versus Traditional Electrosurgery in Subcapsular Tonsillectomy

NCT ID: NCT01193556

Last Updated: 2013-01-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2012-04-30

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).

Conditions

Tonsillitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard of Care

Traditional electrosurgery will be used for the tonsillectomy.

Group Type: ACTIVE_COMPARATOR

Traditional Electrosurgery with scalpel

Intervention Type: DEVICE

Traditional electrosurgery for the tonsillectomy.

PlasmaBlade

The PEAK PlasmaBlade will be used for the tonsillectomy.

Group Type: EXPERIMENTAL

PEAK PlasmaBlade TnA

Intervention Type: DEVICE

The PEAK PlasmaBlade will be used for the tonsillectomy.

Interventions

PEAK PlasmaBlade TnA

The PEAK PlasmaBlade will be used for the tonsillectomy.

Intervention Type: DEVICE

Traditional Electrosurgery with scalpel

Traditional electrosurgery for the tonsillectomy.

Intervention Type: DEVICE

Other Intervention Names

PEAK; PlasmaBlade; Plasma Blade; TnA; Tonsil and Adenoid; Electrosurgery; Electrocautery; Bovie

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

• Minimum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Surgical Technologies

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian Weeks, MD

Role: PRINCIPAL_INVESTIGATOR

Senta Clinic

Mark Spitzer, DO

Role: PRINCIPAL_INVESTIGATOR

Mark Spitzer, DO

Locations

University Surgery Center Merced

Merced, California, United States

Alvarado Hospital

San Diego, California, United States

Countries

United States

Other Identifiers

PEAK VP-00075

Identifier Type: -

Identifier Source: org_study_id