Comparison of Bizact With Electroscissor for Tonsillectomy

NCT ID: NCT03854279

Last Updated: 2019-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-20

Study Completion Date

2020-12-31

Brief Summary

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

Detailed Description

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Conditions

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Tonsillar Hypertrophy, Tonsillitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Bizact

Tonsillectomy will be done With the Bizact device

Group Type EXPERIMENTAL

tonsillar dissection

Intervention Type DEVICE

The tonsils will be removed by bizact device

Electro-scissor

Tonsillectomy will be done With electro-scissors

Group Type ACTIVE_COMPARATOR

tonsillar dissection

Intervention Type DEVICE

The tonsils will be removed by bizact device

Interventions

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tonsillar dissection

The tonsils will be removed by bizact device

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Johan C Ræder

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dept of Anesthesiology, Oslo University Hospital, Ullevaal

Oslo, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Johan Raeder, PhD

Role: CONTACT

004722119690

Facility Contacts

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Johan Rader, PhD

Role: primary

004792249669

Other Identifiers

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Bizact study

Identifier Type: -

Identifier Source: org_study_id

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