NCT03266094CompletedNot Applicable
A Prospective, Multi-center, Single Arm Study of BiZact™ on Children and Adolescents Undergoing Tonsillectomy
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Medtronic - MITG
- Enrollment
- 60
- Locations
- 4
- Primary Endpoint
- Number of Patients With Intra-operative Blood Loss
Study Overview
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)
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
Number of Patients With Intra-operative Blood Loss
Time Frame: During procedure
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
Intra-operative Blood Loss
Time Frame: During procedure
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
Secondary Outcomes
- "Number of Cases/Participants With Analgesic Consumption(28 days post-operatively)
- Number of Cases/Participants Rated Under Different Categories Based on the Performance of the Investigational Device(During Procedure)
- Post-operative Pain(Day 3)
- Number of Cases With Ability to Achieve Hemostasis (Performance of the Investigational Device)(During Procedure)
Investigators
Study Sites (4)
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