Clinical trial NCT03266094: A Study of BiZact™ on Children and Adolescents Undergoing Tonsillectomy
Official title: A Prospective, Multi-center, Single Arm Study of BiZact™ on Children and Adolescents Undergoing Tonsillectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tonsillectomy
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2017-08-29
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

Eligibility criteria: 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)

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.

Primary outcomes:
measure: Intra-operative Blood Loss
timeFrame: During procedure
measure: Number of Patients With Intra-operative Blood Loss
timeFrame: During procedure
Secondary outcomes:
measure: Number of Cases/Participants Rated Under Different Categories Based on the Performance of the Investigational Device
timeFrame: During Procedure
measure: Number of Cases With Ability to Achieve Hemostasis (Performance of the Investigational Device)
timeFrame: During Procedure
measure: "Number of Cases/Participants With Analgesic Consumption
timeFrame: 28 days post-operatively
measure: Post-operative Pain
timeFrame: Post-operative Day 4
measure: Post-operative Pain
timeFrame: Post-operative Day 5
measure: Post-operative Pain
timeFrame: Post-operative Day 6
measure: Post-operative Pain
timeFrame: Post-operative Day 7
measure: Post-operative Pain
timeFrame: Post-operative Day 10
measure: Post-operative Pain
timeFrame: Post-operative Day 14
measure: Post-operative Pain
timeFrame: Post-operative Day 28
measure: Post-operative Pain
timeFrame: Day 1
measure: Post-operative Pain
timeFrame: Day 2
measure: Post-operative Pain
timeFrame: Day 3
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Southeast Clinical Research Associates, LLC
state: North Carolina
city: Charleston
country: United States
facility: Coastal Pediatric Associates
state: South Carolina
Study officials:
affiliation: Coastal Pediatric Research
name: Eugene Brown, MD
role: PRINCIPAL_INVESTIGATOR
References: