Study of Different Kinds of Ear Tubes
|ClinicalTrials.gov Identifier: NCT00809601|
Recruitment Status : Unknown
Verified March 2013 by Magnus von Unge, Danderyd Hospital.
Recruitment status was: Active, not recruiting
First Posted : December 17, 2008
Last Update Posted : March 22, 2013
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 or disease||Intervention/treatment||Phase|
|Recurrent Acute Otitis Media Otitis Media With Effusion With Hearing Impairment||Device: Insertion of a specific type of ventilation tube through the tympanic membrane||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Randomized Controlled Study of Transmyringeal Tubes|
|Study Start Date :||May 2008|
|Estimated Primary Completion Date :||September 2014|
|Estimated Study Completion Date :||September 2015|
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)
- Time to complete expulsion of the ventilation tube from the tympanic membrane [ Time Frame: 45 months ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00809601
|Stockholm, Sweden, 18288|
|Principal Investigator:||Magnus von Unge, MD, PhD||ENT-dept Karolinska Hospital|
|Study Director:||Johan Knutsson, MD||Centre for clinical research Vastmanland|