A Study of BiZact™ on Children and Adolescents Undergoing Tonsillectomy

Completed · Not applicable

Conditions studied: Tonsillectomy

In brief

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.

Key facts

Study ID

NCT03266094

Run by

Medtronic - MITG

People needed

60

Starts

2018-09-30

Expected to finish

2019-07-11

Last updated by the study team

2020-05-21

Who can join

Age: 2 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children and adolescent subjects 2-12 years of age at the time of the procedure, inclusive
• Scheduled to undergo tonsillectomy
• 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)

You may not qualify if…

• Subjects undergoing:
• Tonsillectomy as a result of cancer
• Unilateral tonsillectomy
• Subjects with:
• Known Bleeding disorders
• History of peritonsillar abscess
• Craniofacial disorders
• Down's syndrome (Trisomy 21)
• Cerebral palsy
• 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.)
• Current tobacco use
• Subjects unable to comply with the required study follow-up visits
• Female subjects pregnant at time of procedure
• 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.
• The subject is participating or has participated in any drug or device research study within 30 days of enrollment.

Where it is running

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

Full record on ClinicalTrials.gov

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