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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03266094
Ethics application status
Date submitted
16/08/2017
Date registered
29/08/2017
Date last updated
8/08/2019

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: Bipolar instrument for tonsillectomies - BiZact™: A bipolar instrument for tonsillectomies


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 - 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
Timepoint [1] 0 0
During procedure
Secondary outcome [1] 0 0
Performance of the investigational device (Ability to dissect tonsils) - Ability to dissect tonsils with investigational device via Likert Scale (Very Good, Good, Acceptable, Poor, Very Poor)
Timepoint [1] 0 0
During Procedure
Secondary outcome [2] 0 0
Performance of the investigational device (Ability to achieve hemostasis) - 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)
Timepoint [2] 0 0
During Procedure
Secondary outcome [3] 0 0
Analgesic consumption - Analgesic consumption (standard of care) and concomitant medications (via patient diary).
Timepoint [3] 0 0
28 days post-operatively
Secondary outcome [4] 0 0
Post-operative pain - Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale or the FLACC behavioral pain rating scale (age dependent)
Timepoint [4] 0 0
Post-operative Day 1
Secondary outcome [5] 0 0
Post-operative pain - Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale or the FLACC behavioral pain rating scale (age dependent)
Timepoint [5] 0 0
Post-operative Day 2
Secondary outcome [6] 0 0
Post-operative pain - Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale or the FLACC behavioral pain rating scale (age dependent)
Timepoint [6] 0 0
Post-operative Day 3
Secondary outcome [7] 0 0
Post-operative pain - Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale or the FLACC behavioral pain rating scale (age dependent)
Timepoint [7] 0 0
Post-operative Day 4
Secondary outcome [8] 0 0
Post-operative pain - Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale or the FLACC behavioral pain rating scale (age dependent)
Timepoint [8] 0 0
Post-operative Day 5
Secondary outcome [9] 0 0
Post-operative pain - Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale or the FLACC behavioral pain rating scale (age dependent)
Timepoint [9] 0 0
Post-operative Day 6
Secondary outcome [10] 0 0
Post-operative pain - Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale or the FLACC behavioral pain rating scale (age dependent)
Timepoint [10] 0 0
Post-operative Day 7
Secondary outcome [11] 0 0
Post-operative pain - Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale or the FLACC behavioral pain rating scale (age dependent)
Timepoint [11] 0 0
Post-operative Day 10
Secondary outcome [12] 0 0
Post-operative pain - Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale or the FLACC behavioral pain rating scale (age dependent)
Timepoint [12] 0 0
Post-operative Day 14
Secondary outcome [13] 0 0
Post-operative pain - Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale or the FLACC behavioral pain rating scale (age dependent)
Timepoint [13] 0 0
Post-operative Day 28

Eligibility
Key inclusion criteria
- Children and adolescent subjects 2-21 years of age at the time of the procedure,
inclusive

- Scheduled to undergo tonsillectomy

- The Subject or (if the subject is a minor) Subject's Parent/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
21 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subjects undergoing:

1. Tonsillectomy as a result of cancer

2. Unilateral tonsillectomy

- Subjects with:

1. Known bleeding disorders

2. Current 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

- Subjects unable to comply with the required study follow-up visits

- Female subjects pregnant at time of procedure.

- 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 - 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
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Womens and Children's Hospital - North Adelaide
Recruitment postcode(s) [1] 0 0
5006 - North Adelaide
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
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.
Trial website
https://clinicaltrials.gov/show/NCT03266094
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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

Summary results
Other publications