Status:
COMPLETED
BiZact Tonsillectomy in the Pediatric Population
Lead Sponsor:
Baylor College of Medicine
Conditions:
Tonsillectomy
Tonsillitis Chronic
Eligibility:
All Genders
Up to 18 years
Phase:
NA
Brief Summary
This study has been designed to evaluate how effective the Bizact tonsillectomy device is in reducing operating time and complications that occur after surgery. This device operates in a different way...
Detailed Description
Tonsillectomy is the second most common pediatric surgical procedure, with more than 280,000 performed in children under the age of 15 in the United States in 2010. The most common indications for ton...
Eligibility Criteria
Inclusion
- Tonsil hypertrophy with sleep disordered breathing
- Recurrent tonsillitis or pharyngitis
- Tonsil asymmetry or neoplasm
- Tonsil stones
- Must be able to take ibuprofen
Exclusion
- Bleeding disorders such as von Willebrand's disease or hemophilia
- Down's Syndrome or other craniofacial syndromes
- Revision tonsillectomy cases
Key Trial Info
Start Date :
June 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 25 2024
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT04725305
Start Date
June 6 2021
End Date
July 25 2024
Last Update
July 29 2024
Active Locations (1)
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1
Texas Children's Hospital
Houston, Texas, United States, 77030