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Comparison of Bizact With Electroscissor for Tonsillectomy

Bizact Versus Electroscissor for Adult Tonsillectomy

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03854279
Enrollment
60
Registered
2019-02-26
Start date
2019-02-20
Completion date
2020-12-31
Last updated
2019-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tonsillar Hypertrophy, Tonsillitis

Brief summary

In a randomized, partly double-blind prospective setup we want to compare traditional adult electro-scissor tonsillectomy With ultrasound Technology, Bizact.

Interventions

DEVICEtonsillar dissection

The tonsils will be removed by bizact device

Sponsors

Medtronic
CollaboratorINDUSTRY
Oslo University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
16 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* planned elective tonsillectomy * informed consent

Exclusion criteria

* regular use of analgesics pre-operatively * known tendency of bleeding * not able to communicate in Norwegian

Design outcomes

Primary

MeasureTime frameDescription
Postoperative pain: Number of days With need of analgesics2 weeksNumber of days With need of analgesics

Secondary

MeasureTime frameDescription
Per-operative bleedingper-operativeAmount of bleeding during surgery
Duration of surgery0 - 1 hrtime from start of surgery to end
Postoperative pain: Dose need of pain killers during first 24 hr postoperatively24 hrsDose need of pain killers during first 24 hr postoperatively
Postoperative bleeding2 weeksIncidence of bleeding after discharge

Countries

Norway

Contacts

Primary ContactJohan Raeder, PhD
johan.rader@medisin.uio.no004722119690

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026