Status:
UNKNOWN
Coblation-Tonsillotomy vs Electrocautery-Tonsillectomy for the Treatment of Obstructive Sleep Apnea (OSA) in Children
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
ArthroCare Corporation
Calgary Health Region
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
2-8 years
Phase:
NA
Brief Summary
Removal of the adenoid and tonsils, known as an adenotonsillectomy (AT) is one of the most frequently performed surgical procedures in North America. The two most prevalent indications for this proced...
Eligibility Criteria
Inclusion
- Moderate or severe OSA on PSG (AHI ≥ 5.0)
- Pronounced tonsillar hyperplasia on physical exam
- No previous tonsil or adenoid surgery
- No history of recurrent tonsillitis
- Participants and their families must be willing to comply with follow-up
- Parents/caregivers fluent in English
Exclusion
- Severe co-morbidities, including, but not limited to, poorly controlled asthma, chromosomal abnormalities, and developmental delay
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2013
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00694772
Start Date
June 1 2008
End Date
June 1 2013
Last Update
June 10 2008
Active Locations (1)
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1
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8