PEAK PlasmaBlade TnA Versus Traditional Electrosurgery in Subcapsular Tonsillectomy (PRECISE)
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Tonsillitis |
Device: PEAK PlasmaBlade TnA Device: Traditional Electrosurgery with scalpel |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | A Prospective, Randomized, Double-blinded, Controlled Study to Evaluate Use of the PEAK PlasmaBlade TnA in Subcapsular Tonsillectomy |
- Post-operative Pain [ Time Frame: 10 days immediately following surgery ] [ Designated as safety issue: No ]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.
- Operative Time, Estimated Blood Loss (EBL), Diet Volume and Activity Level [ Time Frame: 1-2 weeks post-operatively ] [ Designated as safety issue: No ]
| Enrollment: | 51 |
| Study Start Date: | July 2010 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Standard of Care
Traditional electrosurgery will be used for the tonsillectomy.
|
Device: Traditional Electrosurgery with scalpel
Traditional electrosurgery for the tonsillectomy.
Other Names:
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|
Experimental: PlasmaBlade
The PEAK PlasmaBlade will be used for the tonsillectomy.
|
Device: PEAK PlasmaBlade TnA
The PEAK PlasmaBlade will be used for the tonsillectomy.
Other Names:
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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| Ages Eligible for Study: | 3 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, California | |
| University Surgery Center Merced | |
| Merced, California, United States, 95340 | |
| Alvarado Hospital | |
| San Diego, California, United States, 92120 | |
| Principal Investigator: | Brian Weeks, MD | Senta Clinic |
| Principal Investigator: | Mark Spitzer, DO | Mark Spitzer, DO |
More Information
No publications provided
| Responsible Party: | Medtronic Surgical Technologies |
| ClinicalTrials.gov Identifier: | NCT01193556 History of Changes |
| Other Study ID Numbers: | PEAK VP-00075 |
| Study First Received: | August 31, 2010 |
| Results First Received: | November 29, 2012 |
| Last Updated: | November 29, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Medtronic Surgical Technologies:
|
Tonsillectomy PlasmaBlade Electrosurgery |
PEAK Surgical Medtronic Advanced Energy Medtronic |
Additional relevant MeSH terms:
|
Tonsillitis Pharyngitis Pharyngeal Diseases Stomatognathic Diseases |
Respiratory Tract Infections Respiratory Tract Diseases Otorhinolaryngologic Diseases |
ClinicalTrials.gov processed this record on June 17, 2013