Status:
COMPLETED
A Study of BiZact™ on Children and Adolescents Undergoing Tonsillectomy
Lead Sponsor:
Medtronic - MITG
Conditions:
Tonsillectomy
Eligibility:
All Genders
2-12 years
Phase:
NA
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,...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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.
Key Trial Info
Start Date :
September 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 11 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03266094
Start Date
September 30 2018
End Date
July 11 2019
Last Update
May 21 2020
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Southeast Clinical Research Associates, LLC
Charlotte, North Carolina, United States, 28210
2
Coastal Pediatric Associates
Charleston, South Carolina, United States, 29407