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Study of Different Kinds of Ear Tubes

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2013 by Magnus von Unge, Danderyd Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00809601
First Posted: December 17, 2008
Last Update Posted: March 22, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Centre for clinical research Vastmanland
Information provided by (Responsible Party):
Magnus von Unge, Danderyd Hospital
  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 (Participant)
Primary Purpose: Treatment
Official Title: Randomized Controlled Study of Transmyringeal Tubes

Resource links provided by NLM:


Further study details as provided by Magnus von Unge, Danderyd Hospital:

Primary Outcome Measures:
  • Time to complete expulsion of the ventilation tube from the tympanic membrane [ Time Frame: 45 months ]

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 10 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Magnus von Unge, Principal investigator, Danderyd Hospital
ClinicalTrials.gov Identifier: NCT00809601     History of Changes
Other Study ID Numbers: 2008/69-31/3
First Submitted: May 2, 2008
First Posted: December 17, 2008
Last Update Posted: March 22, 2013
Last Verified: March 2013

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