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Randomized Controlled Study of Plasmaknife Tonsillectomy Versus Monopolar Tonsillectomy (jPK)

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ClinicalTrials.gov Identifier: NCT00466544
Recruitment Status : Unknown
Verified March 2007 by Children's Hospital of Michigan.
Recruitment status was:  Not yet recruiting
First Posted : April 27, 2007
Last Update Posted : April 27, 2007
Sponsor:
Information provided by:
Children's Hospital of Michigan

April 26, 2007
April 27, 2007
April 27, 2007
May 2007
Not Provided
pain
Same as current
No Changes Posted
  • return to normal activity
  • return to normal diet
  • medication dose taken
Same as current
Not Provided
Not Provided
 
Randomized Controlled Study of Plasmaknife Tonsillectomy Versus Monopolar Tonsillectomy
Not Provided
Study objective is to provide prospective randomized controlled data on pediatric pain levels found in PlasmaKnife tonsillectomy and monopolar tonsillectomy.

This is a prospective, randomized controlled study to compare the efficacy of the Gyrus ACMI PlasmaKnife™ electrosurgical device used with the Gyrus ACMI Workstation versus monopolar electrosurgical device (i.e. Bovie®) for tonsillectomy.

The primary outcome will study the potential for reduced post-operative pain when the PlasmaKnife is used for tonsillectomy compared to a monopolar device. Secondary outcomes such as return to normal diet and activity as well as a range of complications including primary and secondary bleeding will be included in the study.

The study will involve approximately 100 patients at Children’s Hospital of Michigan that meet the criteria for tonsillectomy (with or without adenoidectomy) for infected tonsils or airway obstruction.

The study will be documented through the use of Case Report Forms.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Obstructive Tonsillar Hypertrophy
  • Tonsillitis
  • Device: Plasmaknife
  • Device: Monopolar
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
100
Same as current
Not Provided
Not Provided

Inclusion Criteria:

  • Patient should be between the ages of 4 and 16 years old inclusive.
  • Patient should meet criteria for tonsillectomy.
  • Patient’s guardian able and willing to complete patient diary and keep to the follow-up visit.
  • Guardian able to understand English (written and oral).

Exclusion Criteria:

  • Patient that has active medical implant(s) such as pacemaker, cochlear implant, etc.
  • Patient has abnormal blood coagulation, history of easy bruising, bleeding disorders or uses anti-coagulants.
  • Morbidly obese children (calculated BMI over 39)
  • Patient that has history of malignancy or acute peritonsillar abscess
  • Patient has Sickle Cell disease or is immunocompromised.
  • Patient is pregnant or lactating.
  • Active infection with fever greater than 101.5 degrees F.
  • History of heart disease, diabetes or hypertension (with systolic blood pressure > 160 mmHg).
  • Craniofacial anomaly.
  • Biopsy of tonsil needed to rule out neoplasm.
Sexes Eligible for Study: All
4 Years to 16 Years   (Child)
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00466544
036706MP4F
Yes
Not Provided
Not Provided
Not Provided
Children's Hospital of Michigan
Not Provided
Principal Investigator: David Madgy Detroit Children's Hospital
Children's Hospital of Michigan
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP