Comparison of Bizact With Electroscissor for Tonsillectomy

February 25, 2019 updated by: Johan C Ræder, Oslo University Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0407
        • Recruiting
        • Dept of Anesthesiology, Oslo University Hospital, Ullevaal
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bizact
Tonsillectomy will be done With the Bizact device
Device: tonsillar dissection
The tonsils will be removed by bizact device
Active Comparator: Electro-scissor
Tonsillectomy will be done With electro-scissors
Device: tonsillar dissection
The tonsils will be removed by bizact device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain: Number of days With need of analgesics
Time Frame: 2 weeks
Number of days With need of analgesics
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain: Dose need of pain killers during first 24 hr postoperatively
Time Frame: 24 hrs
Dose need of pain killers during first 24 hr postoperatively
24 hrs
Postoperative bleeding
Time Frame: 2 weeks
Incidence of bleeding after discharge
2 weeks
Per-operative bleeding
Time Frame: per-operative
Amount of bleeding during surgery
per-operative
Duration of surgery
Time Frame: 0 - 1 hr
time from start of surgery to end
0 - 1 hr

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

Medtronic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2019

Primary Completion (Anticipated)

October 31, 2019

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

February 23, 2019

First Submitted That Met QC Criteria

February 25, 2019

First Posted (Actual)

February 26, 2019

Study Record Updates

Last Update Posted (Actual)

February 26, 2019

Last Update Submitted That Met QC Criteria

February 25, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bizact study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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