Chronic Otitis Infections in pédiatric Patients Clinical Trial
Official title:
Evaluation of the Efficiency of KINETUBE® in the Recurrent Chronic Tubal Ear Otitis Care (Otitis Media With Effusion, Atelectatic Otitis or Retraction) in Children With an Age Range of 7-15 Years.
Otitis media are the consequence of bacterial infection. They are characterized by middle
ear inflammations with a collection of fluid behind the eardrum. The effusion stagnates in
the middle ear, can increase acute infection and induce tympanic membrane and inner ear
damages. Delay in language learning can be observed in affected children as well as hearing
problems e.g. constant hearing loss. The two main forms of chronic otitis are otitis media
with effusion (OME) and atelectasis with or without retraction pockets.
To date, insertion of tympanic ventilation tubes (tympanostomy) is the most effective
treatment for otitis media with effusion that has failed to respond to conservative drug
treatments; and for delaying the progression of serious atelectasis. When a first tube did
not allow complete recovery, recurrence is then observed and insertion of new tube is
needed. The repeated tube insertions increase risks linked to general anesthesia and
increase rate of sequelae/complications, such as tympanic membrane perforation.
Kinetube® is a CE-marked medical device, marketed in France and Europe since April 2002.
This device improves the neuronal control mechanism of the pharyngotympanic (Eustachian)
tube, regulating middle ear pressure. This could be an alternative for patients having
recurrence and needing repeated tube insertion, as studies had shown that Kinetube® improved
the opening of the Eustachian tube in patients with otitis media with effusion (OME) and
atelectasis.
These previous clinical studies have shown the feasibility of the use of Kinetube® in
clinical practice. A larger clinical study with a high level of evidence must be performed
to show therapeutic efficacy of the Kinetube® in chronic otitis compared to ventilation tube
insertion.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment