PEAK PlasmaBlade TnA Versus Traditional Electrosurgery in Subcapsular Tonsillectomy
Stopped early · Not applicable
Conditions studied: Tonsillitis
In brief
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).
Key facts
- Study ID
- NCT01193556
- Run by
- Medtronic Surgical Technologies
- People needed
- 51
- Starts
- 2010-07-01
- Expected to finish
- 2012-04-01
- Last updated by the study team
- 2013-01-03
Who can join
Age: 3 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- University Surgery Center Merced — Merced, California, United States
- Alvarado Hospital — San Diego, California, United States
Full record on ClinicalTrials.gov
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