Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03266094
Registration number
NCT03266094
Ethics application status
Date submitted
16/08/2017
Date registered
29/08/2017
Date last updated
21/05/2020
Titles & IDs
Public title
A Study of BiZact™ on Children and Adolescents Undergoing Tonsillectomy
Query!
Scientific title
A Prospective, Multi-center, Single Arm Study of BiZact™ on Children and Adolescents Undergoing Tonsillectomy
Query!
Secondary ID [1]
0
0
MDT17024BZP
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Tonsillectomy
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
0
0
Treatment: Devices
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Intra-operative Blood Loss
Query!
Assessment method [1]
0
0
The study will be considered a success if the mean intra-operative blood loss is less than the mean intra-operative blood loss associated with conventional tonsillectomy in a large meta-analysis
Query!
Timepoint [1]
0
0
During procedure
Query!
Primary outcome [2]
0
0
Number of Patients With Intra-operative Blood Loss
Query!
Assessment method [2]
0
0
The study will be considered a success if the mean intra-operative blood loss is less than the mean intra-operative blood loss associated with conventional tonsillectomy in a large meta-analysis
Query!
Timepoint [2]
0
0
During procedure
Query!
Secondary outcome [1]
0
0
Number of Cases/Participants Rated Under Different Categories Based on the Performance of the Investigational Device
Query!
Assessment method [1]
0
0
Ability to dissect tonsils with investigational device via Likert Scale (Very Good, Good, Acceptable, Poor, Very Poor).
Query!
Timepoint [1]
0
0
During Procedure
Query!
Secondary outcome [2]
0
0
Number of Cases With Ability to Achieve Hemostasis (Performance of the Investigational Device)
Query!
Assessment method [2]
0
0
Ability to achieve hemostasis (arrest of bleeding, as assessed by visual inspection of the Investigator) without the use of other interventions (e.g. energy device or sutures)
Query!
Timepoint [2]
0
0
During Procedure
Query!
Secondary outcome [3]
0
0
"Number of Cases/Participants With Analgesic Consumption
Query!
Assessment method [3]
0
0
Analgesic consumption (standard of care) and concomitant medications (via patient diary).
Query!
Timepoint [3]
0
0
28 days post-operatively
Query!
Secondary outcome [4]
0
0
Post-operative Pain
Query!
Assessment method [4]
0
0
Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 "No Hurt" to a crying face at 10 "Hurts Worst".
Query!
Timepoint [4]
0
0
Post-operative Day 4
Query!
Secondary outcome [5]
0
0
Post-operative Pain
Query!
Assessment method [5]
0
0
Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 "No Hurt" to a crying face at 10 "Hurts Worst".
Query!
Timepoint [5]
0
0
Post-operative Day 5
Query!
Secondary outcome [6]
0
0
Post-operative Pain
Query!
Assessment method [6]
0
0
Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 "No Hurt" to a crying face at 10 "Hurts Worst".
Query!
Timepoint [6]
0
0
Post-operative Day 6
Query!
Secondary outcome [7]
0
0
Post-operative Pain
Query!
Assessment method [7]
0
0
Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 "No Hurt" to a crying face at 10 "Hurts Worst".
Query!
Timepoint [7]
0
0
Post-operative Day 7
Query!
Secondary outcome [8]
0
0
Post-operative Pain
Query!
Assessment method [8]
0
0
Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 "No Hurt" to a crying face at 10 "Hurts Worst".
Query!
Timepoint [8]
0
0
Post-operative Day 10
Query!
Secondary outcome [9]
0
0
Post-operative Pain
Query!
Assessment method [9]
0
0
Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 "No Hurt" to a crying face at 10 "Hurts Worst".
Query!
Timepoint [9]
0
0
Post-operative Day 14
Query!
Secondary outcome [10]
0
0
Post-operative Pain
Query!
Assessment method [10]
0
0
Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 "No Hurt" to a crying face at 10 "Hurts Worst".
Query!
Timepoint [10]
0
0
Post-operative Day 28
Query!
Secondary outcome [11]
0
0
Post-operative Pain
Query!
Assessment method [11]
0
0
Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 "No Hurt" to a crying face at 10 "Hurts Worst".
Query!
Timepoint [11]
0
0
Day 1
Query!
Secondary outcome [12]
0
0
Post-operative Pain
Query!
Assessment method [12]
0
0
Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 "No Hurt" to a crying face at 10 "Hurts Worst".
Query!
Timepoint [12]
0
0
Day 2
Query!
Secondary outcome [13]
0
0
Post-operative Pain
Query!
Assessment method [13]
0
0
Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 "No Hurt" to a crying face at 10 "Hurts Worst".
Query!
Timepoint [13]
0
0
Day 3
Query!
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)
Query!
Minimum age
2
Years
Query!
Query!
Maximum age
12
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
N/A
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
30/09/2018
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
11/07/2019
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
60
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
North Carolina
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
South Carolina
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Medtronic - MITG
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this study is to assess safety and performance with the use of the BiZact™
device in tonsillectomy procedures in children and adolescents.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT03266094
Query!
Trial related presentations / publications
Query!
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
Query!
Contacts
Principal investigator
Name
0
0
Eugene Brown, MD
Query!
Address
0
0
Coastal Pediatric Research
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03266094
Download to PDF