N/A
N=48
A Study of BiZact™ on Adults Undergoing Tonsillectomy
Tonsillectomy
Bottom Line
View on ClinicalTrials.gov: NCT02876575 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: Pain Assessment Using a Visual Analog Scale (VAS) — 5.4 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- A bipolar instrument for tonsillectomies (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic - MITG
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Assessment Using a Visual Analog Scale (VAS) |
1.2 | — |
| PRIMARY Pain Assessment Using a Visual Analog Scale (VAS) |
1.2 | — |
| PRIMARY Pain Assessment Using a Visual Analog Scale (VAS) |
1.2 | — |
| PRIMARY Pain Assessment Using a Visual Analog Scale (VAS) |
1.2 | — |
| PRIMARY Pain Assessment Using a Visual Analog Scale (VAS) |
1.2 | — |
| PRIMARY Pain Assessment Using a Visual Analog Scale (VAS) |
1.2 | — |
| PRIMARY Pain Assessment Using a Visual Analog Scale (VAS) |
1.2 | — |
| PRIMARY Pain Assessment Using a Visual Analog Scale (VAS) |
1.2 | — |
| PRIMARY Pain Assessment Using a Visual Analog Scale (VAS) |
1.2 | — |
| SECONDARY Time to Normal Diet 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 |
12.3 | — |
| SECONDARY Time to Normal Activity 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 |
12.4 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02876575). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.