Efficacy of KNT® (KINETUBE) in Recurrent Chronic Otitis Media in Children

NCT ID: NCT02038400

Last Updated: 2014-01-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30

Brief Summary

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.

Conditions

Chronic Otitis Infections in pédiatric Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

group A

KINETUBE medical Device

Group Type: EXPERIMENTAL

insertion of tympanic ventilation tubes (tympanostomy)

Intervention Type: DEVICE

group B

insertion of tympanic ventilation tubes (tympanostomy)

Group Type: ACTIVE_COMPARATOR

KINETUBE medical Device

Intervention Type: DEVICE

Interventions

KINETUBE medical Device

Intervention Type: DEVICE

insertion of tympanic ventilation tubes (tympanostomy)

Intervention Type: DEVICE

Eligibility Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

LOIC MONDOLONI

Role: STUDY_DIRECTOR

Assistance Publique Hopitaux De Marseille

Locations

Assistance Publique Hopitaux de Marseille

Marseille, , France

Countries

France

Other Identifiers

2013-17

Identifier Type: OTHER

Identifier Source: secondary_id

2013-A00490-45

Identifier Type: -

Identifier Source: org_study_id