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NCT04725305 · ClinicalTrials.gov registry record · NA
BiZact Tonsillectomy in the Pediatric Population
A NA study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 144
- Enrollment target
NCT04725305: Completed NA study, sponsored by Baylor College of Medicine.
NCT04725305 is a NA study that has completed, run by Baylor College of Medicine. The registered enrollment target is 144 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04725305, a NA study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 144 participants
- Enrollment target
Study 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
Primary Outcome
Emergency room visits following tonsillectomy commonly involve poorly controlled pain, dehydration, and post-tonsillectomy hemorrhage. The investigators will tabulate the number of ER visits related to post-operative factors by reviewing charts of tonsillectomy patients two months post-operatively.
Interventions
- PROCEDURE Standard of care
- DEVICE BiZact
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2021-06-06 |
| Est. Completion | 2024-07-25 |
| Phase | NA |
What the finished NCT04725305 record still lists
NCT04725305 is an interventional study that assigns participants to a tested intervention. The registered 144 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard of care is the first listed.
NCT04725305 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04725305 about?
NCT04725305 is a clinical study titled "BiZact Tonsillectomy in the Pediatric Population". 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 1...
What is the current status of trial NCT04725305?
This trial is currently completed. It is a NA study. The enrollment target is 144 participants. The study started on 2021-06-06. Estimated completion is 2024-07-25.
What interventions are being tested in trial NCT04725305?
The interventions under investigation include: Standard of care (PROCEDURE), BiZact (DEVICE).
Who is sponsoring clinical trial NCT04725305?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04725305's enrollment target sits among peer trials
144 706th of 2000 higher than 1,290 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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