TonsillectomyNCT03266094
A Study of BiZact™ on Children and Adolescents Undergoing Tonsillectomy
A study testing BiZact™: A bipolar instrument for tonsillectomies in people with Tonsillectomy, run by Medtronic - MITG at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Tonsillectomy
- What is being tested?
- BiZact™: A bipolar instrument for tonsillectomies
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Sep 2018to 11 Jul 2019
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- Subjects undergoing:
- Tonsillectomy as a result of cancer
- Unilateral tonsillectomy
- Subjects with:
- Known Bleeding disorders
- History of peritonsillar abscess
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Coastal Pediatric Associates
Charleston, South Carolina, 29407
Southeast Clinical Research Associates, LLC
Charlotte, North Carolina, 28210
About this study
Official title: A Prospective, Multi-center, Single Arm 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.
Read the detailed description
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)
- Conditions
- Tonsillectomy
- Being tested
- BiZact™: A bipolar instrument for tonsillectomies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiZact™: 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 Radio frequency (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: BiZact™: A bipolar instrument for tonsillectomies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-operative Blood Loss
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
Measured: During procedure
Number of Patients With Intra-operative Blood Loss
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
Measured: During procedure
Secondary outcomes (13)
Number of Cases/Participants Rated Under Different Categories Based on the Performance of the Investigational Device
Ability to dissect tonsils with investigational device via Likert Scale (Very Good, Good, Acceptable, Poor, Very Poor).
Measured: During Procedure
Number of Cases With Ability to Achieve Hemostasis (Performance of the Investigational Device)
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)
Measured: During Procedure
"Number of Cases/Participants With Analgesic Consumption
Analgesic consumption (standard of care) and concomitant medications (via patient diary).
Measured: 28 days post-operatively
Post-operative Pain
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".
Measured: Post-operative Day 4
Post-operative Pain
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".
Measured: Post-operative Day 5
Post-operative Pain
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".
Measured: Post-operative Day 6
Post-operative Pain
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".
Measured: Post-operative Day 7
Post-operative Pain
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".
Measured: Post-operative Day 10
Post-operative Pain
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".
Measured: Post-operative Day 14
Post-operative Pain
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".
Measured: Post-operative Day 28
Post-operative Pain
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".
Measured: Day 1
Post-operative Pain
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".
Measured: Day 2
Post-operative Pain
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".
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start30 Sep 2018
- Primary completion21 Jun 2019
- Study completion11 Jul 2019
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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eugene Brown, MD, Principal investigator, Coastal Pediatric Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03266094
- Sponsor's protocol ID
- MDT17024BZP
- Status last verified
- May 2020
- First submitted
- 16 Aug 2017
- Last updated
- 21 May 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 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Single Arm Study of BiZact™ on Children and Adolescents Undergoing Tonsillectomy
- ClinicalTrials.gov ID
- NCT03266094
- Acronym / sponsor ID
- MDT17024BZP
- Conditions
- Tonsillectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2018 (actual)
- Primary completion
- 21 Jun 2019 (actual)
- Study completion
- 11 Jul 2019 (actual)
- First posted
- 29 Aug 2017 (actual)
- Results
- Posted 12 May 2020
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 safety and performance with the use of the BiZact™ device in tonsillectomy procedures in children and adolescents.
Detailed description
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)
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: BiZact™: A bipolar instrument for tonsillectomiesA bipolar electrosurgical device that employs Radio frequency (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
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (15 listed)
- Subjects undergoing:
- Subjects with:
- 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.
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 |
|---|---|---|
| BiZact™: 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
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
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
13 secondary outcomes
Number of Cases/Participants Rated Under Different Categories Based on the Performance of the Investigational Device
Time frame: During Procedure
Number of Cases With Ability to Achieve Hemostasis (Performance of the Investigational Device)
Time frame: During Procedure
"Number of Cases/Participants With Analgesic Consumption
Time frame: 28 days post-operatively
Post-operative Pain
Time frame: Post-operative Day 4
Post-operative Pain
Time frame: Post-operative Day 5
Post-operative Pain
Time frame: Post-operative Day 6
Post-operative Pain
Time frame: Post-operative Day 7
Post-operative Pain
Time frame: Post-operative Day 10
Post-operative Pain
Time frame: Post-operative Day 14
Post-operative Pain
Time frame: Post-operative Day 28
Post-operative Pain
Time frame: Day 1
Post-operative Pain
Time frame: Day 2
Post-operative Pain
Time frame: Day 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Tonsillectomy
Not yet recruitingObservational study
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Emergency Delirium, Postoperative Delirium (POD)
Not yet recruiting
Boyle-Davis Mouth Gag Timing in Pediatric Tonsil Surgery
Tonsillectomy and Adenotonsillectomy in Children
Not yet recruitingPhase 3
Effect of Nebulized Lignocaine on Emergence Agitation After Sevoflurane Anesthesia in Pediatric Patients Undergoing Tonsillectomy
Emergence Agitation, Emergence Delirium
Recruiting
Coblator Wand Comparative Analysis
Tonsillectomy, Adenoidectomy
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Suprazygomatic Maxillary Nerve Block in Pediatric Tonsillectomy
Tonsillitis
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.
Eugene Brown, MD principal investigator
Coastal Pediatric Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BiZact™: A bipolar instrument for tonsillectomies in people with Tonsillectomy, run by Medtronic - MITG at 2 sites in United States.
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 15 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 21 May 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. 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 12 May 2020). 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?
Intra-operative Blood Loss (time frame: During procedure). The study lists 2 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 21 May 2020.