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Completed

NCT Number: NCT03266094

A Study of BiZact™ on Children and Adolescents Undergoing Tonsillectomy

The purpose of this study is to assess safety and performance with the use of the BiZact™ device in tonsillectomy procedures in children and adolescents.

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Key information

Conditions

Tonsillectomy

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Southeast Clinical Research Associates, LLC, Charlotte, North Carolina, United States

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About this study

A prospective, multi-center, single arm, study of BiZact™ on children and adolescents undergoing tonsillectomy.

Study Visits:

  • Screening/Baseline
  • Surgery, Day 0
  • Post-Op Follow-up Day 1 - Day 7, Day 10, & Day 14 (Home assessments)
  • Post-Op Follow-up Day 28 (Office Visit)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children and adolescent subjects 2-12 years of age at the time of the procedure, inclusive
  • Scheduled to undergo tonsillectomy
  • The subject and subject's Legally Authorized Representative (LAR) is willing to participate and consents to participate, as documented by signed informed consent form and/ or assent form (as applicable)

Exclusion criteria

  • Subjects undergoing:
  • Tonsillectomy as a result of cancer
  • Unilateral tonsillectomy
  • Subjects with:
  • Known Bleeding disorders
  • History of peritonsillar abscess
  • Craniofacial disorders
  • Down's 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.)
  • Current tobacco use
  • Subjects unable to comply with the required study follow-up visits
  • Female subjects pregnant at time of procedure
  • 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.
  • The subject is participating or has participated in any drug or device research study within 30 days of enrollment.

Treatment and study plan

BiZact™: 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. Intra-operative Blood Loss

    Time frame: During procedure

    The study will be considered a success if the mean intra-operative blood loss is less than the mean intra-operative blood loss associated with conventional tonsillectomy in a large meta-analysis

  2. Number of Patients With Intra-operative Blood Loss

    Time frame: During procedure

    The study will be considered a success if the mean intra-operative blood loss is less than the mean intra-operative blood loss associated with conventional tonsillectomy in a large meta-analysis

Secondary outcomes

  1. Number of Cases/Participants Rated Under Different Categories Based on the Performance of the Investigational Device

    Time frame: During Procedure

    Ability to dissect tonsils with investigational device via Likert Scale (Very Good, Good, Acceptable, Poor, Very Poor).

  2. Number of Cases With Ability to Achieve Hemostasis (Performance of the Investigational Device)

    Time frame: During Procedure

    Ability to achieve hemostasis (arrest of bleeding, as assessed by visual inspection of the Investigator) without the use of other interventions (e.g. energy device or sutures)

  3. "Number of Cases/Participants With Analgesic Consumption

    Time frame: 28 days post-operatively

    Analgesic consumption (standard of care) and concomitant medications (via patient diary).

  4. Post-operative Pain

    Time frame: Post-operative Day 4

    Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 "No Hurt" to a crying face at 10 "Hurts Worst".

  5. Post-operative Pain

    Time frame: Post-operative Day 5

    Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 "No Hurt" to a crying face at 10 "Hurts Worst".

  6. Post-operative Pain

    Time frame: Post-operative Day 6

    Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 "No Hurt" to a crying face at 10 "Hurts Worst".

  7. Post-operative Pain

    Time frame: Post-operative Day 7

    Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 "No Hurt" to a crying face at 10 "Hurts Worst".

  8. Post-operative Pain

    Time frame: Post-operative Day 10

    Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 "No Hurt" to a crying face at 10 "Hurts Worst".

  9. Post-operative Pain

    Time frame: Post-operative Day 14

    Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 "No Hurt" to a crying face at 10 "Hurts Worst".

  10. Post-operative Pain

    Time frame: Post-operative Day 28

    Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 "No Hurt" to a crying face at 10 "Hurts Worst".

  11. Post-operative Pain

    Time frame: Day 1

    Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 "No Hurt" to a crying face at 10 "Hurts Worst".

  12. Post-operative Pain

    Time frame: Day 2

    Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 "No Hurt" to a crying face at 10 "Hurts Worst".

  13. Post-operative Pain

    Time frame: Day 3

    Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 "No Hurt" to a crying face at 10 "Hurts Worst".

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Official study title

A Prospective, Multi-center, Single Arm Study of BiZact™ on Children and Adolescents Undergoing Tonsillectomy

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 29, 2017
Registry last updated
May 21, 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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