At a glance
ClinicalIndex Comparison RecordN/ACompleted· 48 enrolled
Drug / intervention
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 Non-comparative Pilot Study of BiZact™ on Adults Undergoing Tonsillectomy
In Brief
A clinical study evaluating A bipolar instrument for tonsillectomies for Tonsillectomy. Completed, enrolled 48 participants across 2 sites in 2 countries.
Detailed Summary
The purpose of this study is to assess the severity of post-operative pain following the use of the BiZact™ device in adult (≥22 years of age in United States and ≥18 years of age in Europe) tonsillectomy procedures.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTonsillectomy
CountriesSweden, United States
Collaborators--
Timeline
N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedAug 2016
Enrollment StartFeb 2017
Primary CompletionOct 2018
TodayJul 2026
First PostedAug 24, 2016
Enrollment StartFeb 13, 2017
Primary CompletionOct 24, 2018
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 9.9 years ago
Interventions
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.