A Study of BiZact™ on Children and Adolescents Undergoing Tonsillectomy

NCT ID: NCT03266094

Last Updated: 2020-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-30
• Study Completion Date: 2019-07-11

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)

Conditions

Tonsillectomy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

BiZact™: A bipolar instrument for tonsillectomies

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eugene Brown, MD

Role: PRINCIPAL_INVESTIGATOR

Coastal Pediatric Research

Locations

Southeast Clinical Research Associates, LLC

Charlotte, North Carolina, United States

Coastal Pediatric Associates

Charleston, South Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

MDT17024BZP

Identifier Type: -

Identifier Source: org_study_id