TonsillectomyNCT02876575
A Study of BiZact™ on Adults Undergoing Tonsillectomy
A study testing A bipolar instrument for tonsillectomies in people with Tonsillectomy, run by Medtronic - MITG at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tonsillectomy
- What is being tested?
- A bipolar instrument for tonsillectomies
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 13 Feb 2017to 24 Oct 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Subjects undergoing:
- Simultaneous adenoidectomy
- Tonsillectomy as a result of cancer
- Unilateral tonsillectomy
- Current participation in other clinical trials
- Subjects with:
Show all 18Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: 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.
Read the 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)
- Conditions
- Tonsillectomy
- Being tested
- A bipolar instrument for tonsillectomies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A bipolar instrument for tonsillectomiesDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| A bipolar instrument for tonsillectomies | Other | 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. Receives: Device: A bipolar instrument for tonsillectomies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Post-operative Day 14
Secondary outcomes (2)
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
Measured: 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
Measured: Post-operative Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study start13 Feb 2017
- Primary completion24 Oct 2018
- Study completion24 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for TonsillectomyStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ron Karni, MD, Principal investigator, University of Texas at Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02876575
- Sponsor's protocol ID
- COVBZTS0562
- Status last verified
- Mar 2020
- First submitted
- 29 Jul 2016
- Last updated
- 7 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Single Arm Non-comparative Pilot Study of BiZact™ on Adults Undergoing Tonsillectomy
- ClinicalTrials.gov ID
- NCT02876575
- Acronym / sponsor ID
- COVBZTS0562
- Conditions
- Tonsillectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- 13 Feb 2017 (actual)
- Primary completion
- 24 Oct 2018 (actual)
- Study completion
- 24 Oct 2018 (actual)
- First posted
- 24 Aug 2016 (estimated)
- Results
- Posted 26 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A bipolar instrument for tonsillectomies | Other | Device: A bipolar instrument for tonsillectomiesA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (18 listed)
- Subjects undergoing:
- Subjects with:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A bipolar instrument for tonsillectomiesA 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 |
Primary outcome
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
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
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
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
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
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
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
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
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
2 secondary outcomes
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ron Karni, MD principal investigator
University of Texas at Houston
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A bipolar instrument for tonsillectomies in people with Tonsillectomy, run by Medtronic - MITG at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Assessment Using a Visual Analog Scale (VAS) (time frame: Post-operative Day 1). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2020.