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Study of Different Kinds of Ear Tubes

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Centre for clinical research Vastmanland
Information provided by (Responsible Party):
Magnus von Unge, Danderyd Hospital
ClinicalTrials.gov Identifier:
NCT00809601
First received: May 2, 2008
Last updated: March 21, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention
Recurrent Acute Otitis Media
Otitis Media With Effusion With Hearing Impairment
 Device: Insertion of a specific type of ventilation tube through the tympanic membrane

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized Controlled Study of Transmyringeal Tubes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Danderyd Hospital:

Primary Outcome Measures:
  • Time to complete expulsion of the ventilation tube from the tympanic membrane [ Time Frame: 45 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Persistent tympanic membrane perforation [ Time Frame: 45 months ] [ Designated as safety issue: No ]
  • Need for tube extraction (pain or infection) [ Time Frame: 45 months ] [ Designated as safety issue: No ]
  • Pain leading to health care contact [ Time Frame: 45 months ] [ Designated as safety issue: No ]
  • Tube related ear infection [ Time Frame: 45 months ] [ Designated as safety issue: No ]
  • Obstruction of the tube [ Time Frame: 45 months ] [ Designated as safety issue: No ]
  • Presence of myringosclerosis [ Time Frame: 45 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: May 2008
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   1 Year to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children aged 1-10 planned for bilateral ventilation tubes

Exclusion Criteria:

  • Ongoing ear infection
  • Previous insertion of ventilation tube
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00809601

Locations
Sweden
Danderyds Hospital
Stockholm, Sweden, 18288
Sponsors and Collaborators
Danderyd Hospital
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
  More Information

No publications provided

Responsible Party: Magnus von Unge, Principal investigator, Danderyd Hospital
ClinicalTrials.gov Identifier: NCT00809601     History of Changes
Other Study ID Numbers: 2008/69-31/3
Study First Received: May 2, 2008
Last Updated: March 21, 2013
Health Authority: Sweden: Swedish National Council on Medical Ethics

Additional relevant MeSH terms:
Deafness
Hearing Loss
Otitis
Otitis Media
Otitis Media with Effusion
Hearing Disorders
 Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013