N/A
N=60
A Study of BiZact™ on Children and Adolescents Undergoing Tonsillectomy
Tonsillectomy
Bottom Line
View on ClinicalTrials.gov: NCT03266094 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
May 2020
Primary outcome: Primary: Intra-operative Blood Loss — 1.7 mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- BiZact™: A bipolar instrument for tonsillectomies (Device)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Medtronic - MITG
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intra-operative Blood Loss |
1.7 | — |
| PRIMARY Number of Patients With Intra-operative Blood Loss |
29; 9; 20 | — |
| SECONDARY Number of Cases/Participants Rated Under Different Categories Based on the Performance of the Investigational Device |
51; 6; 1; 1; 1 | — |
| SECONDARY Number of Cases With Ability to Achieve Hemostasis (Performance of the Investigational Device) |
60 | — |
| SECONDARY "Number of Cases/Participants With Analgesic Consumption |
58; 56; 55; 54; 53; 49 | — |
| SECONDARY Post-operative Pain |
4.9 | — |
| SECONDARY Post-operative Pain |
4.9 | — |
| SECONDARY Post-operative Pain |
4.9 | — |
| SECONDARY Post-operative Pain |
4.9 | — |
| SECONDARY Post-operative Pain |
4.9 | — |
| SECONDARY Post-operative Pain |
4.9 | — |
| SECONDARY Post-operative Pain |
4.9 | — |
| SECONDARY Post-operative Pain |
4.9 | — |
| SECONDARY Post-operative Pain |
4.9 | — |
| SECONDARY Post-operative Pain |
4.9 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03266094). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.