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Completed

NCT Number: NCT02876575

A 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.

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Key information

Conditions

Tonsillectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sophia Hemmet, Stockholm, Sweden

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

A bipolar instrument for tonsillectomies

Device

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 24, 2016
Registry last updated
Apr 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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