A Study of BiZact™ on Children and Adolescents Undergoing Tonsillectomy

Not Applicable

Completed

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.

Detailed Description: 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)

Recruitment & Eligibility

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

Primary Outcome Measures

Name	Time	Method
Number of Patients With Intra-operative Blood Loss	During procedure	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
Intra-operative Blood Loss	During procedure	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

Secondary Outcome Measures

Name	Time	Method
"Number of Cases/Participants With Analgesic Consumption	28 days post-operatively	Analgesic consumption (standard of care) and concomitant medications (via patient diary).
Number of Cases/Participants Rated Under Different Categories Based on the Performance of the Investigational Device	During Procedure	Ability to dissect tonsils with investigational device via Likert Scale (Very Good, Good, Acceptable, Poor, Very Poor).
Post-operative Pain	Day 3	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".
Number of Cases With Ability to Achieve Hemostasis (Performance of the Investigational Device)	During Procedure	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)

Locations (2): Southeast Clinical Research Associates, LLC
🇺🇸
Charlotte, North Carolina, United States
Coastal Pediatric Associates
🇺🇸
Charleston, South Carolina, United States