Clinical trial NCT02876575: A Study of BiZact™ on Adults Undergoing Tonsillectomy
Official title: A Prospective, Multi-center, Single Arm Non-comparative Pilot Study of BiZact™ on Adults Undergoing Tonsillectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tonsillectomy
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2016-08-24
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: Study Design: Prospective, multi-center, single-arm non-comparative pilot study to assess the severity of post-operative pain with the use of BiZact™ for tonsillectomy.

Study Visits:

* Screening
* Surgery, Day 0
* Post-Op Follow-up Day 1 - Day 7 \& Day 10 (Home assessments)
* Post-Op Follow-up Day 14 (Office Visit)

Eligibility criteria: Inclusion Criteria:

1. Adults (male or female) ≥22 in United States and ≥18 years of age in Europe years of age
2. Scheduled to undergo tonsillectomy
3. Signed informed consent by subject

Exclusion Criteria:

1. Subjects undergoing:

   1. Simultaneous adenoidectomy
   2. Tonsillectomy as a result of cancer
   3. Unilateral tonsillectomy
   4. Current participation in other clinical trials
2. Subjects with:

   1. Current tobacco use
   2. Known bleeding disorders
   3. History of peritonsillar abscess
   4. Craniofacial disorders
   5. Down syndrome (Trisomy 21)
   6. Cerebral palsy
   7. 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.)
   8. Subjects unable to comply with the required study follow-up visits
   9. Pregnancy
3. 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
4. Any subject who is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity)
5. The subject has participated in any drug or device research study within 30 days of enrollment

Primary outcomes:
measure: Pain Assessment Using a Visual Analog Scale (VAS)
timeFrame: Post-operative Day 1
measure: Pain Assessment Using a Visual Analog Scale (VAS)
timeFrame: Post-operative Day 2
measure: Pain Assessment Using a Visual Analog Scale (VAS)
timeFrame: Post-operative Day 3
measure: Pain Assessment Using a Visual Analog Scale (VAS)
timeFrame: Post-operative Day 4
measure: Pain Assessment Using a Visual Analog Scale (VAS)
timeFrame: Post-operative Day 5
measure: Pain Assessment Using a Visual Analog Scale (VAS)
timeFrame: Post-operative Day 6
measure: Pain Assessment Using a Visual Analog Scale (VAS)
timeFrame: Post-operative Day 7
measure: Pain Assessment Using a Visual Analog Scale (VAS)
timeFrame: Post-operative Day 10
measure: Pain Assessment Using a Visual Analog Scale (VAS)
timeFrame: Post-operative Day 14
Secondary outcomes:
measure: 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
timeFrame: Post-operative Day 28
measure: 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
timeFrame: Post-operative Day 28
Other outcomes:
Locations:
city: Houston
country: United States
facility: UT Health
state: Texas
city: Stockholm
country: Sweden
facility: Sophia Hemmet
Study officials:
affiliation: University of Texas at Houston
name: Ron Karni, MD
role: PRINCIPAL_INVESTIGATOR
References: