Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00466544
Status:
UNKNOWN
Last Update Posted:
2007-04-27
First Post:
2007-04-26
Brief Title:
Randomized Controlled Study of Plasmaknife Tonsillectomy Versus Monopolar Tonsillectomy
Sponsor:
Childrens Hospital of Michigan
Organization:
Childrens Hospital of Michigan
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2007-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
jPK
Brief Summary:
Study objective is to provide prospective randomized controlled data on pediatric pain levels found in PlasmaKnife tonsillectomy and monopolar tonsillectomy
Detailed Description:
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 ie 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 Childrens 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
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 Childrens 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None