Tonsillectomy Using BiZact Tonsilletomy Device
NCT04320095 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2020-03-31
Summary
The purpose of this study is to describe how Bizact Tonsillectomy Device might affect operative time and intraoperative blood loss in pediatric patients undergoing tonsillectomy, and compare these parameters to the standard technique in tonsillectomy at our institution, which is electrocautery.
Conditions
- Tonsillectomy
Interventions
- DEVICE
-
Bizact tonsillectomy device
Bizact tonsillectomy device is an advanced bipolar instrument that uses radiofrequency energy and pressure to ligate vessels interposed between its jaws. The energy produced by the device is automatically adjusted based on tissue impedance in an attempt to minimize thermal tissue damage.
Sponsors & Collaborators
-
University of Calgary
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 2 Years
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-06-30
- Primary Completion
- 2021-02-28
- Completion
- 2021-02-28
- FDA Device
- Yes
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