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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03854279
Other study ID # Bizact study
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date February 20, 2019
Est. completion date December 31, 2020

Study information

Verified date February 2019
Source Oslo University Hospital
Contact Johan Raeder, PhD
Phone 004722119690
Email johan.rader@medisin.uio.no
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 31, 2020
Est. primary completion date October 31, 2019
Accepts healthy volunteers No
Gender All
Age group 16 Years to 40 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
tonsillar dissection
The tonsils will be removed by bizact device

Locations

Country Name City State
Norway Dept of Anesthesiology, Oslo University Hospital, Ullevaal Oslo

Sponsors (2)

Lead Sponsor Collaborator
Oslo University Hospital Medtronic

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative pain: Number of days With need of analgesics Number of days With need of analgesics 2 weeks
Secondary Postoperative pain: Dose need of pain killers during first 24 hr postoperatively Dose need of pain killers during first 24 hr postoperatively 24 hrs
Secondary Postoperative bleeding Incidence of bleeding after discharge 2 weeks
Secondary Per-operative bleeding Amount of bleeding during surgery per-operative
Secondary Duration of surgery time from start of surgery to end 0 - 1 hr