Obstructive Tonsillar HypertrophyPhase 4jPKNCT00466544
Randomized Controlled Study of Plasmaknife Tonsillectomy Versus Monopolar Tonsillectomy
A Phase 4 study testing Plasmaknife and Monopolar in people with Obstructive Tonsillar Hypertrophy and Tonsillitis, run by Children's Hospital of Michigan at 1 site in United States.
Trial summary
Study objective is to provide prospective randomized controlled data on pediatric pain levels found in PlasmaKnife tonsillectomy and monopolar tonsillectomy. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Obstructive Tonsillar Hypertrophy, Tonsillitis
- What is being tested?
- Plasmaknife and Monopolar
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 16 years
- All sexes
- Child
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Detroit Children's Hospital
Detroit, Michigan, 48201
David Madgy, 313-745-9048, dnmadgy@comcast.net
Mary Ross, (313) 745-9050, mmross@dmc.org
About this study
Study objective is to provide prospective randomized controlled data on pediatric pain levels found in PlasmaKnife tonsillectomy and monopolar tonsillectomy.
Read the 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.
- Conditions
- Obstructive Tonsillar Hypertrophy, Tonsillitis
- Being tested
- Plasmaknife, Monopolar
- Keywords
- Chronic tonsillitis, Recurrent tonsillitis
- Medical subject headings
- Tonsillitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlasmaknifeDevice
MonopolarDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
Secondary outcomes (3)
return to normal activity
return to normal diet
medication dose taken
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2007 (estimated)
- Study startMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Tonsillar HypertrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Michigan
- Sponsor type
- University, hospital or other
- Investigators
- David Madgy, Principal investigator, Detroit Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00466544
- Sponsor's protocol ID
- 036706MP4F
- Acronym
- jPK
- Status last verified
- Mar 2007
- First submitted
- 26 Apr 2007
- Last updated
- 27 Apr 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study of Plasmaknife Tonsillectomy Versus Monopolar Tonsillectomy
- ClinicalTrials.gov ID
- NCT00466544
- Acronym / sponsor ID
- jPK / 036706MP4F
- Conditions
- Obstructive Tonsillar Hypertrophy, Tonsillitis
- Keywords
- Chronic tonsillitis, Recurrent tonsillitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Children's Hospital of MichiganUniversity, hospital or other
- Study start
- May 2007
- First posted
- 27 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study objective is to provide prospective randomized controlled data on pediatric pain levels found in PlasmaKnife tonsillectomy and monopolar tonsillectomy.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasmaknife | Device | – |
| Monopolar | Device | – |
Primary outcome
pain
3 secondary outcomes
return to normal activity
return to normal diet
medication dose taken
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2007.
Related trials for Obstructive Tonsillar Hypertrophy
Recruiting
Photobiomodulation for Pediatric Hypertrophic Tonsils
Pediatric Sleep Apnea, Obstructive Sleep Apnea
Not yet recruiting
Randomized Clinical Trial for Tonsil Surgery in Adults With Obstructive Sleep Apnea and Enlarged Tonsils
Sleep Apnea, Obstructives, Tonsil Hypertrophy
Recruiting
Lateral Pharyngoplasty Outcomes in Children Undergoing Tonsillectomy
Sleep-Disordered Breathing, Sleep Apnea Syndromes in Children
Not yet recruiting
Tonsillectomy vs. Tonsillotomy in Adults With Obstructive Sleep Apnea
Obstructive Sleep Apnea, Tonsillar Hypertrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Madgy principal investigator
Detroit Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Plasmaknife and Monopolar in people with Obstructive Tonsillar Hypertrophy and Tonsillitis, run by Children's Hospital of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2007.