Tonsillectomy Using BiZact Tonsilletomy Device
BiZact Versus Electrocautery in Tonsillectomy: A Single-Center Randomized Controlled Trial
1 other identifier
interventional
48
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2020
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2020
CompletedFirst Posted
Study publicly available on registry
March 24, 2020
CompletedStudy Start
First participant enrolled
June 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2021
CompletedMarch 31, 2020
March 1, 2020
8 months
March 22, 2020
March 30, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Operative time
The study will be considered success if the mean intra operative time using Bizact device is less than that using electrocautery
during the procedure
Secondary Outcomes (1)
Intraoperative blood loss
during the procedure
Study Arms (4)
Bizact device for one tonsil
EXPERIMENTALBizact tonsillecotmy device which is an advanced bipolar device using radiofrequency and pressure to ligate the encountered vessels during tonsillectomy.
Electrocautery for second tonsil
ACTIVE COMPARATORElectrocautery is the standard technique used at our institution.
Bizact device for both tonsils
EXPERIMENTALConsecutive cases of tonsillectomy will be done using Bizact device and compare the operative time collectively for those cases and compare it to same number of cases done using the standard procedure ( Electrocautery)
Electrocautery for both tonsils
ACTIVE COMPARATORAs explained on the above arm description
Interventions
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.
Eligibility Criteria
You may qualify if:
- Children scheduled for tonsillectomy at Alberta Children Hospital
- Tonsillectomy for either recurrent tonsillitis or sleep-disordered breathing.
You may not qualify if:
- Craniofacial abnormalities
- Bleeding disorders
- Complex medical background
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2020
First Posted
March 24, 2020
Study Start
June 1, 2020
Primary Completion
February 1, 2021
Study Completion
February 1, 2021
Last Updated
March 31, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share