An interventional study of KINETUBE medical Device and insertion of tympanic ventilation tubes (tympanostomy) in Chronic Otitis Infections in pédiatric Patients, sponsored by Assistance Publique Hopitaux De Marseille. Status unknown at 1 site in France. Open to participants aged 7 Years to 15 Years. Per ClinicalTrials.gov, last updated 2014-01-16.
Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Treatment
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.
246 studies on the registry are indexed under Otitis; 21 are open to participants now.
This study's enrollment of 140 is above the median of 126 across 173 interventional studies indexed under Otitis.
Browse Otitis studies →Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 148 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
KINETUBE medical Device
Device: insertion of tympanic ventilation tubes (tympanostomy)
insertion of tympanic ventilation tubes (tympanostomy)
Device: KINETUBE medical Device
Difference of the deficiency of hearing
Difference of the deficiency of hearing(audition) in decibels HL ( Hearing Level), measured by examination of tonal audiometry (average of the losses in air conductions with the frequencies 500-1000-2000 Hz), between the inclusion and 12 months after the implementation of the treatment(processing)
Time frame: 3 years
This study is status unknown, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Assistance Publique Hopitaux De Marseille