CompletedNot Applicable

BiZact Tonsillectomy in the Pediatric Population

United States144 participantsStarted 2021-06-06

Plain-language 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 than the standard device that is used for most tonsillectomies. In 2019, a study was conducted in 186 children and adults using this device in tonsillectomies. Results showed lower blood loss and shortened time in surgery. However, the rate for bleeding as a complication after surgery was the same as other procedures that are used in tonsillectomy

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Tonsil hypertrophy with sleep disordered breathing * Recurrent tonsillitis or pharyngitis * Tonsil asymmetry or neoplasm * Tonsil stones * Must be able to take ibuprofen Exclusion Criteria: * Bleeding disorders such as von Willebrand's disease or hemophilia * Down's Syndrome or other craniofacial syndromes * Revision tonsillectomy cases

What they're measuring

Emergency room visits

Timeframe: 2 months

Intra-operative blood loss

Timeframe: Duration of surgery

Trial details

NCT IDNCT04725305

SponsorBaylor College of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-25

View on ClinicalTrials.gov More Tonsillectomy trials