A Study of BiZact™ on Adults Undergoing Tonsillectomy

Study Overview
=================
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)

Official Title
-----------------
A Prospective, Multi-center, Single Arm Non-comparative Pilot Study of BiZact™ on Adults Undergoing Tonsillectomy

Conditions
-----------------
Tonsillectomy

Intervention / Treatment
-----------------
* Device: A bipolar instrument for tonsillectomies


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A bipolar instrument for tonsillectomies<br>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. | Device: A bipolar instrument for tonsillectomies<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Assessment Using a Visual Analog Scale (VAS) | 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 will be analyzed at each post-operative assessment: at days 1 through 7, 10 and 14. This pain score will be assessed quantitatively using the VAS scale and qualitatively using the below subgroups: No Pain: VAS= 0 Mild Pain: VAS > 0 and < 4 Moderate: VAS ≥ 4 and < 7 Severe: VAS ≥ 7 | Post-operative Day 1 | 
| Pain Assessment Using a Visual Analog Scale (VAS) | 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 will be analyzed at each post-operative assessment: at days 1 through 7, 10 and 14. This pain score will be assessed quantitatively using the VAS scale and qualitatively using the below subgroups: No Pain: VAS= 0 Mild Pain: VAS > 0 and < 4 Moderate: VAS ≥ 4 and < 7 Severe: VAS ≥ 7 | Post-operative Day 2 | 
| Pain Assessment Using a Visual Analog Scale (VAS) | 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 will be analyzed at each post-operative assessment: at days 1 through 7, 10 and 14. This pain score will be assessed quantitatively using the VAS scale and qualitatively using the below subgroups: No Pain: VAS= 0 Mild Pain: VAS > 0 and < 4 Moderate: VAS ≥ 4 and < 7 Severe: VAS ≥ 7 | Post-operative Day 3 | 
| Pain Assessment Using a Visual Analog Scale (VAS) | 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 will be analyzed at each post-operative assessment: at days 1 through 7, 10 and 14. This pain score will be assessed quantitatively using the VAS scale and qualitatively using the below subgroups: No Pain: VAS= 0 Mild Pain: VAS > 0 and < 4 Moderate: VAS ≥ 4 and < 7 Severe: VAS ≥ 7 | Post-operative Day 4 | 
| Pain Assessment Using a Visual Analog Scale (VAS) | 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 will be analyzed at each post-operative assessment: at days 1 through 7, 10 and 14. This pain score will be assessed quantitatively using the VAS scale and qualitatively using the below subgroups: No Pain: VAS= 0 Mild Pain: VAS > 0 and < 4 Moderate: VAS ≥ 4 and < 7 Severe: VAS ≥ 7 | Post-operative Day 5 | 
| Pain Assessment Using a Visual Analog Scale (VAS) | 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 will be analyzed at each post-operative assessment: at days 1 through 7, 10 and 14. This pain score will be assessed quantitatively using the VAS scale and qualitatively using the below subgroups: No Pain: VAS= 0 Mild Pain: VAS > 0 and < 4 Moderate: VAS ≥ 4 and < 7 Severe: VAS ≥ 7 | Post-operative Day 6 | 
| Pain Assessment Using a Visual Analog Scale (VAS) | 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 will be analyzed at each post-operative assessment: at days 1 through 7, 10 and 14. This pain score will be assessed quantitatively using the VAS scale and qualitatively using the below subgroups: No Pain: VAS= 0 Mild Pain: VAS > 0 and < 4 Moderate: VAS ≥ 4 and < 7 Severe: VAS ≥ 7 | Post-operative Day 7 | 
| Pain Assessment Using a Visual Analog Scale (VAS) | 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 will be analyzed at each post-operative assessment: at days 1 through 7, 10 and 14. This pain score will be assessed quantitatively using the VAS scale and qualitatively using the below subgroups: No Pain: VAS= 0 Mild Pain: VAS > 0 and < 4 Moderate: VAS ≥ 4 and < 7 Severe: VAS ≥ 7 | Post-operative Day 10 | 
| Pain Assessment Using a Visual Analog Scale (VAS) | 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 will be analyzed at each post-operative assessment: at days 1 through 7, 10 and 14. This pain score will be assessed quantitatively using the VAS scale and qualitatively using the below subgroups: No Pain: VAS= 0 Mild Pain: VAS > 0 and < 4 Moderate: VAS ≥ 4 and < 7 Severe: VAS ≥ 7 | Post-operative Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Ability to return to Normal, subject's baseline, diet. EORTC Quality of Life Questionnaire (EORTC QLQ -H&N35) will be analyzed at each post-operative assessment: at days 1 through 7, 10 and 14. The module consists of 35 questions assessing symptoms and side effects of treatment, social function, and body image/sexuality. The head and neck cancer module incorporates seven multi-item scales that assess pain, swallowing, senses (taste and smell), speech, social eating, social contact, and sexuality. There are also eleven single items. For all items and scales, high scores indicate more problems. This score will be assessed qualitatively by asking if they have experienced symptoms or problems using the below subgroups: Not at all: 1 A little: 2 Quite a bit: 3 Very much: 4 | Post-operative Day 28 | 
| 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 | Ability to return to Normal, subject's baseline, activity. EORTC Quality of Life Questionnaire (EORTC QLQ -H&N35) will be analyzed at each post-operative assessment: at days 1 through 7, 10 and 14. The module consists of 35 questions assessing symptoms and side effects of treatment, social function, and body image/sexuality. The head and neck cancer module incorporates seven multi-item scales that assess pain, swallowing, senses (taste and smell), speech, social eating, social contact, and sexuality. There are also eleven single items. For all items and scales, high scores indicate more problems. This score will be assessed qualitatively by asking if they have experienced symptoms or problems using the below subgroups: Not at all: 1 A little: 2 Quite a bit: 3 Very much: 4 | Post-operative Day 28 |