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.
Device: A bipolar instrument for tonsillectomies
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Locations near you
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Full eligibility criteria for NCT02876575
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Adults (male or female) ≥22 in United States and ≥18 years of age in Europe years of age
Scheduled to undergo tonsillectomy
Signed informed consent by subject
Tonsillectomy as a result of cancer
Current participation in other clinical trials
Current tobacco use
Known bleeding disorders
History of peritonsillar abscess
Down syndrome (Trisomy 21)
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.)
Subjects unable to comply with the required study follow-up visits
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
Any subject who is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity)
The subject has participated in any drug or device research study within 30 days of enrollment
All locations for NCT02876575
United States (1)
University of Texas Health Science
Houston, Texas, United States, 77030
Trial results for NCT02876575
Participant Flow: Overall Study
48 / 48
Completed / Started
Serious Adverse Events
0 / 96
Affected / At Risk
Other Adverse Events
6 / 48
Affected / At Risk
View full eligibility
Tris trial is registered with FDA with number: NCT02876575. The sponsor of the trial is Medtronic - MITG and it is looking for 48 volunteers for the current phase.
Official trial title: A Prospective, Multi-center, Single Arm Non-comparative Pilot Study of BiZact™ on Adults Undergoing Tonsillectomy
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