A Study of BiZact™ on Adults Undergoing Tonsillectomy

• ClinicalTrials.gov Identifier: NCT02876575
• Recruitment Status: Completed
• First Posted: August 24, 2016
• Results First Posted: December 26, 2019
• Last Update Posted: April 7, 2020
• Sponsor: Medtronic - MITG
• Information provided by (Responsible Party): Medtronic - MITG

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Tonsillectomy	Device: A bipolar instrument for tonsillectomies	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 48 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective, Multi-center, Single Arm Non-comparative Pilot Study of BiZact™ on Adults Undergoing Tonsillectomy
• Actual Study Start Date: February 13, 2017
• Actual Primary Completion Date: October 24, 2018
• Actual Study Completion Date: October 24, 2018

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. Pain Assessment Using a Visual Analog Scale (VAS) [ Time Frame: Post-operative Day 1 ]

   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
2. Pain Assessment Using a Visual Analog Scale (VAS) [ Time Frame: Post-operative Day 2 ]

   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
3. Pain Assessment Using a Visual Analog Scale (VAS) [ Time Frame: Post-operative Day 3 ]

   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
4. Pain Assessment Using a Visual Analog Scale (VAS) [ Time Frame: Post-operative Day 4 ]

   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
5. Pain Assessment Using a Visual Analog Scale (VAS) [ Time Frame: Post-operative Day 5 ]

   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
6. Pain Assessment Using a Visual Analog Scale (VAS) [ Time Frame: Post-operative Day 6 ]

   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
7. Pain Assessment Using a Visual Analog Scale (VAS) [ Time Frame: Post-operative Day 7 ]

   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
8. Pain Assessment Using a Visual Analog Scale (VAS) [ Time Frame: Post-operative Day 10 ]

   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
9. Pain Assessment Using a Visual Analog Scale (VAS) [ Time Frame: Post-operative Day 14 ]

   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

Secondary Outcome Measures :

1. 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 [ Time Frame: Post-operative Day 28 ]

   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
2. 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 [ Time Frame: Post-operative Day 28 ]

   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

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, Texas

UT Health

Houston, Texas, United States, 77030

Sweden

Sophia Hemmet

Stockholm, Sweden

Sponsors and Collaborators

Medtronic - MITG

Investigators

• Principal Investigator: Ron Karni, MD; University of Texas at Houston

  Study Documents (Full-Text)

Documents provided by Medtronic - MITG:

Study Protocol and Statistical Analysis Plan  [PDF] September 25, 2018

More Information

• Responsible Party: Medtronic - MITG
• ClinicalTrials.gov Identifier: NCT02876575
• Other Study ID Numbers: COVBZTS0562
• First Posted: August 24, 2016
• Results First Posted: December 26, 2019
• Last Update Posted: April 7, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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