A Study of BiZact™ on Adults Undergoing Tonsillectomy

Tonsillectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02876575
• Other study ID #: COVBZTS0562
• Status: Completed
• Phase: N/A
• Start date: February 13, 2017
• Est. completion date: October 24, 2018

Study information

• Verified date: March 2020
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 24, 2018
• Est. primary completion date: October 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tonsillectomy

Intervention

Device:
• A bipolar instrument for tonsillectomies
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.

Locations

Country	Name	City	State
Sweden	Sophia Hemmet	Stockholm
United States	UT Health	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Countries where clinical trial is conducted

United States,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
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	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