Efficacy of KNT® (KINETUBE) in Recurrent Chronic Otitis Media in Children (KINETUBE)
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|ClinicalTrials.gov Identifier: NCT02038400|
Recruitment Status : Unknown
Verified March 2013 by Assistance Publique Hopitaux De Marseille.
Recruitment status was: Active, not recruiting
First Posted : January 16, 2014
Last Update Posted : January 16, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Otitis Infections in pédiatric Patients||Device: KINETUBE medical Device Device: insertion of tympanic ventilation tubes (tympanostomy)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||November 2013|
|Estimated Primary Completion Date :||July 2016|
Experimental: group A
KINETUBE medical Device
Device: insertion of tympanic ventilation tubes (tympanostomy)
Active Comparator: group B
insertion of tympanic ventilation tubes (tympanostomy)
Device: KINETUBE medical Device
- Difference of the deficiency of hearing [ Time Frame: 3 years ]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)
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): NCT02038400
|Assistance Publique Hopitaux de Marseille|
|Marseille, France, 13354|
|Study Director:||LOIC MONDOLONI||Assistance Publique Hopitaux De Marseille|