Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
48 participants
INTERVENTIONAL
2020-06-30
2021-02-28
Brief Summary
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Detailed Description
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Operative time will be assessed in 2 ways: 1). By using blade-tipped electrocautery on one tonsil and the BiZact device on the other tonsil for same patient; and 2). using electrocautery for removal of both tonsils and comparing the operative time to an equal number of cases wherein the BiZact device was used for removal of both tonsils.
With regard to intra operative bleeding, it will be quantified into one of 3 groups: 1). No blood in suction tubing, 2). blood in suction tubing but not in the suction canister, and 3). blood in the suction canister.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Bizact device for one tonsil
Bizact tonsillecotmy device which is an advanced bipolar device using radiofrequency and pressure to ligate the encountered vessels during tonsillectomy.
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.
Electrocautery for second tonsil
Electrocautery is the standard technique used at our institution.
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.
Bizact device for both tonsils
Consecutive 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)
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.
Electrocautery for both tonsils
As explained on the above arm description
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Tonsillectomy for either recurrent tonsillitis or sleep-disordered breathing.
Exclusion Criteria
2. Bleeding disorders
3. Complex medical background
2 Years
18 Years
ALL
Yes
Sponsors
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University of Calgary
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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REB19-0088
Identifier Type: -
Identifier Source: org_study_id