A Study of BiZact™ on Children and Adolescents Undergoing Tonsillectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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A prospective, multi-center, single arm, study of BiZact™ on children and adolescents undergoing tonsillectomy. Study Visits: Screening/Baseline Surgery, Day 0 Post-Op Follow-up Day 1 - Day 7, Day 10, & Day 14 (Home assessments) Post-Op Follow-up Day 28 (Office Visit)

Official Title
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A Prospective, Multi-center, Single Arm Study of BiZact™ on Children and Adolescents Undergoing Tonsillectomy

Conditions
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Tonsillectomy

Intervention / Treatment
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* Device: BiZact™: A bipolar instrument for tonsillectomies


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children and adolescent subjects 2-12 years of age at the time of the procedure, inclusive Scheduled to undergo tonsillectomy 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) Exclusion Criteria: Subjects undergoing: Tonsillectomy as a result of cancer Unilateral tonsillectomy Subjects with: Known Bleeding disorders History of peritonsillar abscess Craniofacial disorders Down's syndrome (Trisomy 21) Cerebral palsy 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.) 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 of less than 6 months. The subject is participating or has participated in any drug or device research study within 30 days of enrollment.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A bipolar instrument for tonsillectomies<br>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. | Device: BiZact™: A bipolar instrument for tonsillectomies<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | During procedure | 
| Number of Patients With 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 | During procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Cases/Participants Rated Under Different Categories Based on the Performance of the Investigational Device | Ability to dissect tonsils with investigational device via Likert Scale (Very Good, Good, Acceptable, Poor, Very Poor). | During Procedure | 
| Number of Cases With Ability to Achieve Hemostasis (Performance of the Investigational Device) | 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) | During Procedure | 
| Number of Cases/Participants With Analgesic Consumption | Analgesic consumption (standard of care) and concomitant medications (via patient diary). | 28 days post-operatively | 
| Post-operative Pain | 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. | Post-operative Day 4 | 
| Post-operative Pain | 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. | Post-operative Day 5 | 
| Post-operative Pain | 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. | Post-operative Day 6 | 
| Post-operative Pain | 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. | Post-operative Day 7 | 
| Post-operative Pain | 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. | Post-operative Day 10 | 
| Post-operative Pain | 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. | Post-operative Day 14 | 
| Post-operative Pain | 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. | Post-operative Day 28 | 
| Post-operative Pain | 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. | Day 1 | 
| Post-operative Pain | 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. | Day 2 | 
| Post-operative Pain | 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. | Day 3 |