We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Randomized Controlled Study of Plasmaknife Tonsillectomy Versus Monopolar Tonsillectomy (jPK)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2007 by Children's Hospital of Michigan.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00466544
First Posted: April 27, 2007
Last Update Posted: April 27, 2007
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.
Information provided by:
Children's Hospital of Michigan
  Purpose
Study objective is to provide prospective randomized controlled data on pediatric pain levels found in PlasmaKnife tonsillectomy and monopolar tonsillectomy.

Condition Intervention Phase
Obstructive Tonsillar Hypertrophy Tonsillitis Device: Plasmaknife Device: Monopolar Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Michigan:

Primary Outcome Measures:
  • pain

Secondary Outcome Measures:
  • return to normal activity
  • return to normal diet
  • medication dose taken

Estimated Enrollment: 100
Study Start Date: May 2007
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   4 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Michigan
Detroit Children's Hospital Not yet recruiting
Detroit, Michigan, United States, 48201
Contact: David Madgy    313-745-9048    dnmadgy@comcast.net   
Contact: Mary Ross    (313) 745-9050    mmross@dmc.org   
Principal Investigator: David Madgy         
Sponsors and Collaborators
Children's Hospital of Michigan
Investigators
Principal Investigator: David Madgy Detroit Children's Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00466544     History of Changes
Other Study ID Numbers: 036706MP4F
First Submitted: April 26, 2007
First Posted: April 27, 2007
Last Update Posted: April 27, 2007
Last Verified: March 2007

Keywords provided by Children's Hospital of Michigan:
Chronic tonsillitis
Recurrent tonsillitis

Additional relevant MeSH terms:
Hypertrophy
Tonsillitis
Pathological Conditions, Anatomical
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases


To Top