TonsillectomyNCT04320095
Tonsillectomy Using BiZact Tonsilletomy Device
A study testing Bizact tonsillectomy device in people with Tonsillectomy, run by University of Calgary.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Tonsillectomy
- What is being tested?
- Bizact tonsillectomy device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Jun 2020to Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Children scheduled for tonsillectomy at Alberta Children Hospital
- Tonsillectomy for either recurrent tonsillitis or sleep-disordered breathing.
Who cannot join
- Craniofacial abnormalities
- Bleeding disorders
- Complex medical background
Trial locations and contacts
No sites are listed yet.
Warren Yunker, MD, PhD contact
About this study
Official title: BiZact Versus Electrocautery in Tonsillectomy: A Single-Center Randomized Controlled Trial
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.
Read the detailed description
It is a prospective, interventional, single-center study on the performance of Bizact tonsillectomy device on children undergoing tonsillectomy.The required parameters concerning operative time and intra operative blood loss will be obtained during the procedure.There will be no extra clinical visits for the participants.
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
- Tonsillectomy
- Being tested
- Bizact tonsillectomy device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bizact tonsillectomy deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Bizact device for one tonsil | Experimental | Bizact tonsillecotmy device which is an advanced bipolar device using radiofrequency and pressure to ligate the encountered vessels during tonsillectomy. Receives: Device: Bizact tonsillectomy device |
| Electrocautery for second tonsil | Active comparator | Electrocautery is the standard technique used at our institution. Receives: Device: Bizact tonsillectomy device |
| Bizact device for both tonsils | Experimental | 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) Receives: Device: Bizact tonsillectomy device |
| Electrocautery for both tonsils | Active comparator | As explained on the above arm description Receives: Device: Bizact tonsillectomy device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
The study will be considered success if the mean intra operative time using Bizact device is less than that using electrocautery
Measured: during the procedure
Secondary outcomes (1)
Intraoperative blood loss
The study will be considered success if the mean intraoperative blood loss using Bizact is less than Electrocautery
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study startJun 2020 (estimated)
- Primary completionFeb 2021 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TonsillectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04320095
- Sponsor's protocol ID
- REB19-0088
- Status last verified
- Mar 2020
- First submitted
- 22 Mar 2020
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BiZact Versus Electrocautery in Tonsillectomy: A Single-Center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04320095
- Acronym / sponsor ID
- REB19-0088
- Conditions
- Tonsillectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Jun 2020 (estimated)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 24 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
It is a prospective, interventional, single-center study on the performance of Bizact tonsillectomy device on children undergoing tonsillectomy.The required parameters concerning operative time and intra operative blood loss will be obtained during the procedure.There will be no extra clinical visits for the participants.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Bizact device for one tonsil | Experimental | Device: Bizact tonsillectomy deviceBizact tonsillecotmy device which is an advanced bipolar device using radiofrequency and pressure to ligate the encountered vessels during tonsillectomy. |
| Electrocautery for second tonsil | Active comparator | Device: Bizact tonsillectomy deviceElectrocautery is the standard technique used at our institution. |
| Bizact device for both tonsils | Experimental | Device: Bizact tonsillectomy deviceConsecutive 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 comparator | Device: Bizact tonsillectomy deviceAs explained on the above arm description |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Children scheduled for tonsillectomy at Alberta Children Hospital
- Tonsillectomy for either recurrent tonsillitis or sleep-disordered breathing.
Key exclusion criteria (3 listed)
- Craniofacial abnormalities
- Bleeding disorders
- Complex medical background
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bizact tonsillectomy deviceBizact 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. | Device | Bizact device for both tonsils, Bizact device for one tonsil, Electrocautery for both tonsils, Electrocautery for second tonsil |
Primary outcome
Operative time
Time frame: during the procedure
The study will be considered success if the mean intra operative time using Bizact device is less than that using electrocautery
1 secondary outcome
Intraoperative blood loss
Time frame: during the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Warren Yunker, MD, PhD contact
Questions about this trial
What is this clinical trial studying?
A study testing Bizact tonsillectomy device in people with Tonsillectomy, run by University of Calgary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Khaloud Al Bahri, MD (587-888-1284, khaloud.albahri@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time (time frame: during the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.