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A Study of BiZact™ on Adults Undergoing Tonsillectomy

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ClinicalTrials.gov Identifier: NCT02876575
Recruitment Status : Active, not recruiting
First Posted : August 24, 2016
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
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 : May 31, 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tonsillitis

Arm Intervention/treatment
A bipolar instrument for tonsillectomies 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.




Primary Outcome Measures :
  1. 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. [ Time Frame: Post-operative Day 1 ]
    Pain assessment using a Visual Analog Scale (VAS)

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

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

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

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

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

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

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

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


Secondary Outcome Measures :
  1. Ability to return to normal diet and 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 1 ]
    EORTC Quality of Life Questionnaire (EORTC QLQ -H&N35)

  2. Ability to return to normal diet and 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 2 ]
    EORTC Quality of Life Questionnaire (EORTC QLQ -H&N35)

  3. Ability to return to normal diet and 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 3 ]
    EORTC Quality of Life Questionnaire (EORTC QLQ -H&N35)

  4. Ability to return to normal diet and 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 4 ]
    EORTC Quality of Life Questionnaire (EORTC QLQ -H&N35)

  5. Ability to return to normal diet and 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 5 ]
    EORTC Quality of Life Questionnaire (EORTC QLQ -H&N35)

  6. Ability to return to normal diet and 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 6 ]
    EORTC Quality of Life Questionnaire (EORTC QLQ -H&N35)

  7. Ability to return to normal diet and 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 7 ]
    EORTC Quality of Life Questionnaire (EORTC QLQ -H&N35)

  8. Ability to return to normal diet and 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 10 ]
    EORTC Quality of Life Questionnaire (EORTC QLQ -H&N35)

  9. Ability to return to normal diet and 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 14 ]
    EORTC Quality of Life Questionnaire (EORTC QLQ -H&N35)



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02876575


Locations
United States, Texas
UT Health
Houston, Texas, United States, 77030
Sweden
Sophia Hemmet
Stockholm, Sweden
Sponsors and Collaborators
Medtronic - MITG

Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT02876575     History of Changes
Other Study ID Numbers: COVBZTS0562
First Posted: August 24, 2016    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: At study completion.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes