Informations générales (source: ClinicalTrials.gov)
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. (KINETUBE)
Interventional
N/A
Assistance Publique Hopitaux De Marseille (Voir sur ClinicalTrials)
novembre 2013
29 juin 2024
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.
Etablissements
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
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Assistance Publique Hopitaux de Marseille - 13354 - Marseille - France | Contact (sur clinicalTrials) |
Critères
Tous
Inclusion Criteria:
- Patients from 7 to 15 years old
- Patients presenting recurrent otitis media with effusion, or atelectasis (with or
without retraction pocket), with presence of fluid behind the eardrum, and
conductive hearing loss ≥ 30 dB
- Patients who had undergone one (or more) previous tympanoplasty tube insertion, and
who need a new one
- Patients whose parents (or parental authority holders) have given voluntary signed
informed consent
- Patients affiliated to the French health insurance system or similar
- Patients from 7 to 15 years old
- Patients presenting recurrent otitis media with effusion, or atelectasis (with or
without retraction pocket), with presence of fluid behind the eardrum, and
conductive hearing loss ≥ 30 dB
- Patients who had undergone one (or more) previous tympanoplasty tube insertion, and
who need a new one
- Patients whose parents (or parental authority holders) have given voluntary signed
informed consent
- Patients affiliated to the French health insurance system or similar
- Age less than 7 years old and higher than 15 years old
- Patients needing tympanoplasty tube insertion for the first time
- Patients who had already received Kinetube® treatment
- Patients presenting purulent acute otitis media
- Patients presenting otitis media with effusion following barotrauma
- Patients presenting neck dysfunction (cleft lip and cleft palate)
- Patients presenting nasopharynx and nasal cavities tumoral process (except adenoids)
- Patients with a narrow ear canal that does not allow tympanometry exam
- Patients with a history of irradiation of the ear, nose and throat
- Patient who underwent a previous surgery of the soft palate, or with paralysis of
the soft palate
- Patients presenting cilia-related disease or chronic immunodeficiency
- Patients with Down syndrome
- Patients taking part, or having taken part, into other clinical study for the
treatment of chronic otitis media