BiZact Tonsillectomy in the Pediatric Population
CompletedNot applicableNCT04725305
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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
Study details
- Official title
- BiZact Tonsillectomy
- Conditions
- Tonsillectomy
- Tonsillitis Chronic
- Hemorrhage
- Postoperative Pain
- Postoperative Hemorrhage
- Surgery--Complications
- Otorhinolaryngologic Diseases
- Interventions
- Device: BiZact
- Procedure: Standard of care
- Sponsor
- Baylor College of Medicine
- Start date
- 2021-06-06
- Primary completion
- 2024-07-25
- Sex
- All
- Age range
- to 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04725305