A Study of BiZact™ on Children and Adolescents Undergoing Tonsillectomy
A Prospective, Multi-center, Single Arm Study of BiZact™ on Children and Adolescents Undergoing Tonsillectomy
1 other identifier
interventional
60
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2018
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2017
CompletedFirst Posted
Study publicly available on registry
August 29, 2017
CompletedStudy Start
First participant enrolled
September 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 21, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 11, 2019
CompletedResults Posted
Study results publicly available
May 12, 2020
CompletedMay 21, 2020
May 1, 2020
9 months
August 16, 2017
March 28, 2020
May 12, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Intra-operative Blood Loss
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
During procedure
Number of Patients With Intra-operative Blood Loss
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
During procedure
Secondary Outcomes (13)
Number of Cases/Participants Rated Under Different Categories Based on the Performance of the Investigational Device
During Procedure
Number of Cases With Ability to Achieve Hemostasis (Performance of the Investigational Device)
During Procedure
"Number of Cases/Participants With Analgesic Consumption
28 days post-operatively
Post-operative Pain
Post-operative Day 4
Post-operative Pain
Post-operative Day 5
- +8 more secondary outcomes
Study Arms (1)
A bipolar instrument for tonsillectomies
OTHERA 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.
Interventions
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.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtronic - MITGlead
Study Sites (2)
Southeast Clinical Research Associates, LLC
Charlotte, North Carolina, 28210, United States
Coastal Pediatric Associates
Charleston, South Carolina, 29407, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Melody LaBeau, Director of Clinical Operations
- Organization
- Medtronic
Study Officials
- PRINCIPAL INVESTIGATOR
Eugene Brown, MD
Coastal Pediatric Research
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2017
First Posted
August 29, 2017
Study Start
September 30, 2018
Primary Completion
June 21, 2019
Study Completion
July 11, 2019
Last Updated
May 21, 2020
Results First Posted
May 12, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share