Tonsillar Hypertrophy, TonsillitisPhase 4NCT03854279
Comparison of Bizact With Electroscissor for Tonsillectomy
A Phase 4 study testing tonsillar dissection in people with Tonsillar Hypertrophy, Tonsillitis, run by Oslo University Hospital at 1 site in Norway.
Trial summary
In a randomized, partly double-blind prospective setup we want to compare traditional adult electro-scissor tonsillectomy With ultrasound Technology, Bizact. Read more about this study
- Who is it for?
- Ages 16 to 40 years
- Conditions the study is for
- Tonsillar Hypertrophy, Tonsillitis
- What is being tested?
- tonsillar dissection
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- 20 Feb 2019to 31 Dec 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 16 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- planned elective tonsillectomy
- informed consent
Who cannot join
- regular use of analgesics pre-operatively
- known tendency of bleeding
- not able to communicate in Norwegian
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Dept of Anesthesiology, Oslo University Hospital, Ullevaal
Oslo, 0407
Johan Rader, PhD, 004792249669, johan.rader@medisin.uio.no
About this study
Official title: Bizact Versus Electroscissor for Adult Tonsillectomy
In a randomized, partly double-blind prospective setup we want to compare traditional adult electro-scissor tonsillectomy With ultrasound Technology, Bizact.
- Conditions
- Tonsillar Hypertrophy, Tonsillitis
- Being tested
- tonsillar dissection
- Medical subject headings
- Tonsillitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tonsillar dissectionDevice
The tonsils will be removed by bizact device
| Study group | Role | What they receive |
|---|---|---|
| Bizact | Experimental | Tonsillectomy will be done With the Bizact device Receives: Device: tonsillar dissection |
| Electro-scissor | Active comparator | Tonsillectomy will be done With electro-scissors Receives: Device: tonsillar dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain: Number of days With need of analgesics
Number of days With need of analgesics
Measured: 2 weeks
Secondary outcomes (4)
Postoperative pain: Dose need of pain killers during first 24 hr postoperatively
Dose need of pain killers during first 24 hr postoperatively
Measured: 24 hrs
Postoperative bleeding
Incidence of bleeding after discharge
Measured: 2 weeks
Per-operative bleeding
Amount of bleeding during surgery
Measured: per-operative
Duration of surgery
time from start of surgery to end
Measured: 0 - 1 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start20 Feb 2019
- Primary completion31 Oct 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tonsillar Hypertrophy, TonsillitisStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Johan C Ræder, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03854279
- Sponsor's protocol ID
- Bizact study
- Status last verified
- Feb 2019
- First submitted
- 23 Feb 2019
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bizact Versus Electroscissor for Adult Tonsillectomy
- ClinicalTrials.gov ID
- NCT03854279
- Acronym / sponsor ID
- Bizact study
- Conditions
- Tonsillar Hypertrophy, Tonsillitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 20 Feb 2019 (actual)
- Primary completion
- 31 Oct 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 26 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In a randomized, partly double-blind prospective setup we want to compare traditional adult electro-scissor tonsillectomy With ultrasound Technology, Bizact.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bizact | Experimental | Device: tonsillar dissectionTonsillectomy will be done With the Bizact device |
| Electro-scissor | Active comparator | Device: tonsillar dissectionTonsillectomy will be done With electro-scissors |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- planned elective tonsillectomy
- informed consent
Key exclusion criteria (3 listed)
- regular use of analgesics pre-operatively
- known tendency of bleeding
- not able to communicate in Norwegian
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 |
|---|---|---|
| tonsillar dissectionThe tonsils will be removed by bizact device | Device | Bizact, Electro-scissor |
Primary outcome
Postoperative pain: Number of days With need of analgesics
Time frame: 2 weeks
Number of days With need of analgesics
4 secondary outcomes
Postoperative pain: Dose need of pain killers during first 24 hr postoperatively
Time frame: 24 hrs
Postoperative bleeding
Time frame: 2 weeks
Per-operative bleeding
Time frame: per-operative
Duration of surgery
Time frame: 0 - 1 hr
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tonsillar dissection in people with Tonsillar Hypertrophy, Tonsillitis, run by Oslo University Hospital at 1 site in Norway.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johan Raeder, PhD (004722119690, johan.rader@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain: Number of days With need of analgesics (time frame: 2 weeks). 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 26 Feb 2019.