A Study of BiZact™ on Adults Undergoing Tonsillectomy

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

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.

Study Overview

• Status: Completed
• Conditions: Tonsillectomy
• Intervention / Treatment: Device: A bipolar instrument for tonsillectomies

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)

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Sophia Hemmet
• United States
  • Texas
    • Houston, Texas, United States, 77030
      • UT Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	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.

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

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Principal Investigator: Ron Karni, MD, University of Texas at Houston

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2017
• Primary Completion (Actual): October 24, 2018
• Study Completion (Actual): October 24, 2018

Study Registration Dates

• First Submitted: July 29, 2016
• First Submitted That Met QC Criteria: August 17, 2016
• First Posted (Estimate): August 24, 2016

Study Record Updates

• Last Update Posted (Actual): April 7, 2020
• Last Update Submitted That Met QC Criteria: March 30, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: COVBZTS0562

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes