- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00466544
Randomized Controlled Study of Plasmaknife Tonsillectomy Versus Monopolar Tonsillectomy (jPK)
Study Overview
Status
Conditions
Intervention / Treatment
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 (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
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Michigan
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Detroit, Michigan, United States, 48201
- Detroit Children's Hospital
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Contact:
- David Madgy
- Phone Number: 313-745-9048
- Email: dnmadgy@comcast.net
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Contact:
- Mary Ross
- Phone Number: (313) 745-9050
- Email: mmross@dmc.org
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Principal Investigator:
- David Madgy
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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pain
|
Secondary Outcome Measures
Outcome Measure |
---|
return to normal activity
|
return to normal diet
|
medication dose taken
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David Madgy, Detroit Children's Hospital
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 036706MP4F
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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