Study of Different Kinds of Ear Tubes - Full Text View

Sponsors and Collaborators:	Danderyd Hospital Centre for clinical research Vastmanland
Information provided by:	Danderyd Hospital
ClinicalTrials.gov Identifier:	NCT00809601

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

Genetics Home Reference related topics: nonsyndromic deafness

MedlinePlus related topics: Ear Infections Hearing Disorders and Deafness

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Parallel Assignment
Official Title:	Randomized Controlled Study of Transmyringeal Tubes

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 2014
Estimated Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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. We 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)

Arms

Assigned Interventions

1: Experimental

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.

We 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

Contacts

Contact: Magnus von Unge, MD, PhD

46-217-3835

magnus.von.unge@ltv.se

Locations

Sweden
Danderyds Hospital	Recruiting
Stockholm, Sweden, 18288
Contact: Claudia Priwin, MD, PhD 46-8-655-5407 claudia.priwin@karolinska.se
Contact: Lotta Hessén-Soderman, MD, PhD 46-8-655-5407
Principal Investigator: Claudia Priwin, MD, PhD

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:	ENT-dept Danderyd Hospital ( Danderyd Hospital )
Study ID Numbers:	2008/69-31/3
Study First Received:	May 2, 2008
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00809601 History of Changes
Health Authority:	Sweden: Swedish National Council on Medical Ethics

Study placed in the following topic categories:

Signs and Symptoms
Sensation Disorders
Hearing Disorders
Deafness
Otorhinolaryngologic Diseases
Otitis Media with Effusion

Otitis
Otitis Media
Neurologic Manifestations
Hearing Loss
Ear Diseases
Recurrence

Additional relevant MeSH terms:

Signs and Symptoms
Sensation Disorders
Hearing Disorders
Deafness
Otorhinolaryngologic Diseases
Otitis Media with Effusion

Otitis
Nervous System Diseases
Otitis Media
Neurologic Manifestations
Hearing Loss
Ear Diseases

ClinicalTrials.gov processed this record on May 07, 2009