A Study of BiZact™ on Children and Adolescents Undergoing Tonsillectomy

Tonsillectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03266094
• Other study ID #: MDT17024BZP
• Status: Completed
• Phase: N/A
• Start date: September 30, 2018
• Est. completion date: July 11, 2019

Study information

• Verified date: May 2020
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 11, 2019
• Est. primary completion date: June 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tonsillectomy

Intervention

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.

Locations

Country	Name	City	State
United States	Coastal Pediatric Associates	Charleston	South Carolina
United States	Southeast Clinical Research Associates, LLC	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	"Number of Cases/Participants With Analgesic Consumption	Analgesic consumption (standard of care) and concomitant medications (via patient diary).	28 days post-operatively
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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