At a glance
ClinicalIndex Comparison RecordN/ACompleted· 60 enrolled
Drug / intervention
BiZact™: A bipolar instrument for tonsillectomiesdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Multi-center, Single Arm Study of BiZact™ on Children and Adolescents Undergoing Tonsillectomy
In Brief
A clinical study evaluating BiZact™: A bipolar instrument for tonsillectomies for Tonsillectomy. Completed, enrolled 60 participants across 2 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTonsillectomy
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
201820192020202120222023202420252026
First PostedAug 2017
Enrollment StartSep 2018
Primary CompletionJun 2019
Study CompletionJul 2019
TodayJul 2026
First PostedAug 29, 2017
Enrollment StartSep 30, 2018
Primary CompletionJun 21, 2019
Study CompletionJul 11, 2019
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 8.8 years ago
Interventions
BiZact™: A bipolar instrument for tonsillectomiesdevice
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.