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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00466544
Other study ID # 036706MP4F
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received April 26, 2007
Last updated April 26, 2007
Start date May 2007

Study information

Verified date March 2007
Source Children's Hospital of Michigan
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Study objective is to provide prospective randomized controlled data on pediatric pain levels found in PlasmaKnife tonsillectomy and monopolar tonsillectomy.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 4 Years to 16 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Plasmaknife

Monopolar


Locations

Country Name City State
United States Detroit Children's Hospital Detroit Michigan

Sponsors (1)

Lead Sponsor Collaborator
Children's Hospital of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary pain
Secondary return to normal activity
Secondary return to normal diet
Secondary medication dose taken
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