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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03266094




Registration number
NCT03266094
Ethics application status
Date submitted
16/08/2017
Date registered
29/08/2017

Titles & IDs
Public title
A Study of BiZact™ on Children and Adolescents Undergoing Tonsillectomy
Scientific title
A Prospective, Multi-center, Single Arm Study of BiZact™ on Children and Adolescents Undergoing Tonsillectomy
Secondary ID [1] 0 0
MDT17024BZP
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tonsillectomy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - BiZact™: A bipolar instrument for tonsillectomies

Other: A bipolar instrument for tonsillectomies - A bipolar electrosurgical device that employs Radio frequency (RF) energy and pressure to ligate vessels interposed between its jaws which can then be transected using the built in knife deployed by the device trigger.


Treatment: Devices: BiZact™: A bipolar instrument for tonsillectomies
A bipolar electrosurgical device that employs RF energy and pressure to ligate vessels interposed between its jaws which can then be transected using the built in knife deployed by the device trigger.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Intra-operative Blood Loss
Timepoint [1] 0 0
During procedure
Primary outcome [2] 0 0
Number of Patients With Intra-operative Blood Loss
Timepoint [2] 0 0
During procedure
Secondary outcome [1] 0 0
Number of Cases/Participants Rated Under Different Categories Based on the Performance of the Investigational Device
Timepoint [1] 0 0
During Procedure
Secondary outcome [2] 0 0
Number of Cases With Ability to Achieve Hemostasis (Performance of the Investigational Device)
Timepoint [2] 0 0
During Procedure
Secondary outcome [3] 0 0
"Number of Cases/Participants With Analgesic Consumption
Timepoint [3] 0 0
28 days post-operatively
Secondary outcome [4] 0 0
Post-operative Pain
Timepoint [4] 0 0
Post-operative Day 4
Secondary outcome [5] 0 0
Post-operative Pain
Timepoint [5] 0 0
Post-operative Day 5
Secondary outcome [6] 0 0
Post-operative Pain
Timepoint [6] 0 0
Post-operative Day 6
Secondary outcome [7] 0 0
Post-operative Pain
Timepoint [7] 0 0
Post-operative Day 7
Secondary outcome [8] 0 0
Post-operative Pain
Timepoint [8] 0 0
Post-operative Day 10
Secondary outcome [9] 0 0
Post-operative Pain
Timepoint [9] 0 0
Post-operative Day 14
Secondary outcome [10] 0 0
Post-operative Pain
Timepoint [10] 0 0
Post-operative Day 28
Secondary outcome [11] 0 0
Post-operative Pain
Timepoint [11] 0 0
Day 1
Secondary outcome [12] 0 0
Post-operative Pain
Timepoint [12] 0 0
Day 2
Secondary outcome [13] 0 0
Post-operative Pain
Timepoint [13] 0 0
Day 3

Eligibility
Key inclusion criteria
1. Children and adolescent subjects 2-12 years of age at the time of the procedure, inclusive
2. Scheduled to undergo tonsillectomy
3. The subject and subject's Legally Authorized Representative (LAR) is willing to participate and consents to participate, as documented by signed informed consent form and/ or assent form (as applicable)
Minimum age
2 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subjects undergoing:

1. Tonsillectomy as a result of cancer
2. Unilateral tonsillectomy
2. Subjects with:

1. Known Bleeding disorders
2. History of peritonsillar abscess
3. Craniofacial disorders
4. Down's syndrome (Trisomy 21)
5. Cerebral palsy
6. Major heart disease (including but not limited to; right-sided heart failure, left-sided heart failure, congestive heart failure, coronary artery disease, arrhythmias, chronic heart failure, acute heart failure, etc.)
7. Current tobacco use
3. Subjects unable to comply with the required study follow-up visits
4. Female subjects pregnant at time of procedure
5. The subject has comorbidities which, in the opinion of the Investigator, will not be appropriate for the study or the subject has an estimated life expectancy of less than 6 months.
6. The subject is participating or has participated in any drug or device research study within 30 days of enrollment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/09/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/07/2019
Sample size
Target
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
North Carolina
Country [2] 0 0
United States of America
State/province [2] 0 0
South Carolina

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Medtronic - MITG
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Eugene Brown, MD
Address 0 0
Coastal Pediatric Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03266094