A Study of BiZact™ on Children and Adolescents Undergoing Tonsillectomy

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

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.

Study Overview

• Status: Completed
• Conditions: Tonsillectomy
• Intervention / Treatment: Device: BiZact™: A bipolar instrument for tonsillectomies

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)

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • Southeast Clinical Research Associates, LLC
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Coastal Pediatric Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Principal Investigator: Eugene Brown, MD, Coastal Pediatric Research

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2018
• Primary Completion (Actual): June 21, 2019
• Study Completion (Actual): July 11, 2019

Study Registration Dates

• First Submitted: August 16, 2017
• First Submitted That Met QC Criteria: August 28, 2017
• First Posted (Actual): August 29, 2017

Study Record Updates

• Last Update Posted (Actual): May 21, 2020
• Last Update Submitted That Met QC Criteria: May 12, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: MDT17024BZP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes