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PlasmaKnife vs Monopolar Tonsillectomy for Enlarged Tonsils (jPK Trial)

Phase 4
Waitlist Available
Led By David Madgy
Research Sponsored by Children's Hospital of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient should be between the ages of 4 and 16 years old inclusive
Patient should meet criteria for tonsillectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

jPK Trial Summary

This trial is investigating whether PlasmaKnife tonsillectomy results in less pain for children than monopolar tonsillectomy.

Who is the study for?
This trial is for children aged 4-16 who need a tonsillectomy. They must have a guardian who can document their recovery and attend follow-up visits. Kids with pacemakers, bleeding disorders, severe obesity, cancer history, immune issues, or certain chronic diseases cannot participate.Check my eligibility
What is being tested?
The study compares pain levels in kids undergoing two types of tonsil removal surgeries: PlasmaKnife tonsillectomy versus the standard monopolar technique. It's designed to randomly assign participants to one of these surgical methods.See study design
What are the potential side effects?
Potential side effects may include pain at the surgery site, bleeding, swelling, infection risk post-surgery and reactions specific to the type of surgery received (PlasmaKnife or monopolar).

jPK Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 4 and 16 years old.
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I am eligible for a tonsil removal surgery.
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My guardian understands English both in writing and speaking.

jPK Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
pain
Secondary outcome measures
medication dose taken
return to normal activity
return to normal diet

Find a Location

Who is running the clinical trial?

Children's Hospital of MichiganLead Sponsor
25 Previous Clinical Trials
4,193 Total Patients Enrolled
David MadgyPrincipal InvestigatorDetroit Children's Hospital

Media Library

Monopolar Tonsillectomy Clinical Trial Eligibility Overview. Trial Name: NCT00466544 — Phase 4
Enlarged Tonsils Research Study Groups:
Enlarged Tonsils Clinical Trial 2023: Monopolar Tonsillectomy Highlights & Side Effects. Trial Name: NCT00466544 — Phase 4
Monopolar Tonsillectomy 2023 Treatment Timeline for Medical Study. Trial Name: NCT00466544 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are geriatric patients considered eligible for this trial?

"This medical study seeks patients aged between 4 and 16 years old."

Answered by AI

Are recruitment efforts for the experiment still ongoing?

"Judging from the details on clinicaltrials.gov, this investigation is not currently searching for participants as it has not been updated since April 26th 2007. Although there are no openings with this trial at present, 95 other trials are actively recruiting right now."

Answered by AI

Is my profile compatible with the criteria for this medical trial?

"This study is searching for 100 minors between 4 and 16 years of age with a current diagnosis of tonsillitis. To be eligible, the patient must meet all criteria: they should fall within this specified age range, conform to conditions necessitating a tonsillectomy; and have an adult guardian who is willing and able to record information in a diary as well as attend follow-up appointments."

Answered by AI

Has this treatment achieved federal endorsement?

"Assigning a score of 3, our Power team has deemed this Phase 4 treatment to be safe based on its approval status."

Answered by AI
~6 spots leftby Mar 2025