Study of Different Kinds of Ear Tubes

March 21, 2013 updated by: Magnus von Unge, Danderyd Hospital

Randomized Controlled Study of Transmyringeal Tubes

There are different kinds of ear tubes that may be inserted into the tympanic membrane to relieve recurrent acute otitis and hearing impairment due to otitis media with effusion. The tubes differ in size, shape and material.

No-one knows if there are differences between the different kinds of tubes regarding complications.

The investigators' hypothesis is that there is differences between the different kinds of tubes regarding complications.

To test the investigators' hypothesis, the investigators are about to conduct a randomized controlled study of four kinds of tubes having two different material and two different shapes.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

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

  • Sweden
      • Stockholm, Sweden, 18288
        • Danderyds Hospital

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

1 year to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children aged 1-10 planned for bilateral ventilation tubes

Exclusion Criteria:

  • Ongoing ear infection
  • Previous insertion of ventilation tube

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Device: Insertion of a specific type of ventilation tube through the tympanic membrane

The ventilation tubes are tested using one type in one ear and another type as an active comparator in the other ear.

The investigators will test in total 4 different kinds of tubes. Four different combinations of tubes will be tested.

The first combination will test:

"Shepard tube" (double flanged, Fluoroplastic) vs "Donaldson tube" (double flanged, silicone)

The second combination will test:

"Straight tube" (single flanged, Fluoroplastic) vs "Armstrong" (single flanged, silicone)

The third combination will test:

"Armstrong" (single flanged, silicone) vs "Donaldson tube" (double flanged, silicone)

The fourth combination will test:

"Straight tube" (single flanged, Fluoroplastic) vs "Shepard tube" (double flanged, Fluoroplastic)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to complete expulsion of the ventilation tube from the tympanic membrane
Time Frame: 45 months
45 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Persistent tympanic membrane perforation
Time Frame: 45 months
45 months
Need for tube extraction (pain or infection)
Time Frame: 45 months
45 months
Pain leading to health care contact
Time Frame: 45 months
45 months
Tube related ear infection
Time Frame: 45 months
45 months
Obstruction of the tube
Time Frame: 45 months
45 months
Presence of myringosclerosis
Time Frame: 45 months
45 months

Collaborators and Investigators

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

Sponsor

Danderyd Hospital

Collaborators

Centre for clinical research Vastmanland

Investigators

  • Principal Investigator: Magnus von Unge, MD, PhD, ENT-dept Karolinska Hospital
  • Study Director: Johan Knutsson, MD, Centre for clinical research Vastmanland

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

May 1, 2008

Primary Completion (Anticipated)

September 1, 2014

Study Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

May 2, 2008

First Submitted That Met QC Criteria

December 16, 2008

First Posted (Estimate)

December 17, 2008

Study Record Updates

Last Update Posted (Estimate)

March 22, 2013

Last Update Submitted That Met QC Criteria

March 21, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008/69-31/3

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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