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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00466544 |
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Date of registration:
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26/04/2007 |
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Primary sponsor: |
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Public title:
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Randomized Controlled Study of Plasmaknife Tonsillectomy Versus Monopolar Tonsillectomy
jPK |
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Scientific title:
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Date of first enrolment:
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May 2007 |
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Target sample size:
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100 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00466544 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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David Madgy |
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Address:
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Telephone:
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313-745-9048 |
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Email:
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dnmadgy@comcast.net |
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Affiliation:
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Name:
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David Madgy |
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Address:
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Telephone:
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Email:
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Affiliation:
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Detroit Children's Hospital |
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Key inclusion & exclusion criteria
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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.
Age minimum:
4 Years
Age maximum:
16 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Obstructive Tonsillar Hypertrophy
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Tonsillitis
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Intervention(s)
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Device: Monopolar
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Device: Plasmaknife
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Secondary Outcome(s)
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medication dose taken
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return to normal activity
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return to normal diet
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Secondary ID(s)
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036706MP4F
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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