A Study of BiZact™ on Children and Adolescents Undergoing Tonsillectomy

Medtronic

Status: Completed

Conditions: Tonsillectomy

Treatments: Device: BiZact™: A bipolar instrument for tonsillectomies

Study type: Interventional

Funder types: Industry

Identifiers

NCT03266094

MDT17024BZP

Details and patient eligibility

About

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.

Full 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)

Enrollment: 60 patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

A bipolar instrument for tonsillectomies

Other group

Description:

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.

Treatment:

Device: BiZact™: A bipolar instrument for tonsillectomies