Status:
TERMINATED
PEAK PlasmaBlade TnA Versus Traditional Electrosurgery in Subcapsular Tonsillectomy
Lead Sponsor:
Medtronic Surgical Technologies
Conditions:
Tonsillitis
Eligibility:
All Genders
3+ years
Phase:
NA
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 varia...
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 P...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT01193556
Start Date
July 1 2010
End Date
April 1 2012
Last Update
January 3 2013
Active Locations (2)
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1
University Surgery Center Merced
Merced, California, United States, 95340
2
Alvarado Hospital
San Diego, California, United States, 92120