A Study of BiZact™ on Adults Undergoing Tonsillectomy
Completed · Not applicable
Conditions studied: Tonsillectomy
In brief
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.
Key facts
- Study ID
- NCT02876575
- Run by
- Medtronic - MITG
- People needed
- 48
- Starts
- 2017-02-13
- Expected to finish
- 2018-10-24
- Last updated by the study team
- 2020-04-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Subjects undergoing:
- Simultaneous adenoidectomy
- Tonsillectomy as a result of cancer
- Unilateral tonsillectomy
- Current participation in other clinical trials
- Subjects with:
- Current tobacco use
- Known bleeding disorders
- History of peritonsillar abscess
- Craniofacial disorders
- Down 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.)
- Subjects unable to comply with the required study follow-up visits
- Pregnancy
- 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
Where it is running
- UT Health — Houston, Texas, United States
- Sophia Hemmet — Stockholm, Sweden
Full record on ClinicalTrials.gov
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