Randomized Controlled Study of Plasmaknife Tonsillectomy Versus Monopolar Tonsillectomy (jPK)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Tonsillar Hypertrophy Tonsillitis||Device: Plasmaknife Device: Monopolar||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Study Start Date :||May 2007|
- return to normal activity
- return to normal diet
- medication dose taken
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00466544
|United States, Michigan|
|Detroit Children's Hospital||Not yet recruiting|
|Detroit, Michigan, United States, 48201|
|Contact: David Madgy 313-745-9048 firstname.lastname@example.org|
|Contact: Mary Ross (313) 745-9050 email@example.com|
|Principal Investigator: David Madgy|
|Principal Investigator:||David Madgy||Detroit Children's Hospital|