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Study of Different Kinds of Ear Tubes

NCT00809601 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2013-03-22

No results posted yet for this study

Summary

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.

Conditions

  • Recurrent Acute Otitis Media
  • Otitis Media With Effusion With Hearing Impairment

Interventions

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)

Sponsors & Collaborators

  • Centre for clinical research Vastmanland

    collaborator UNKNOWN

  • Danderyd Hospital

    lead OTHER

Principal Investigators

  • Magnus von Unge, MD, PhD · ENT-dept Karolinska Hospital

  • Johan Knutsson, MD · Centre for clinical research Vastmanland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2014-09-30
Completion
2015-09-30

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00809601 on ClinicalTrials.gov