Chronic Otitis Infections in pédiatric PatientsKINETUBENCT02038400
Efficacy of KNT® (KINETUBE) in Recurrent Chronic Otitis Media in Children
A study testing KINETUBE medical Device and insertion of tympanic ventilation tubes (tympanostomy) in people with Chronic Otitis Infections in pédiatric Patients, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 15 years
- Conditions the study is for
- Chronic Otitis Infections in pédiatric Patients
- What is being tested?
- KINETUBE medical Device and insertion of tympanic ventilation tubes (tympanostomy)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2013to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Being tested
- KINETUBE medical Device, insertion of tympanic ventilation tubes (tympanostomy)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KINETUBE medical DeviceDevice
insertion of tympanic ventilation tubes (tympanostomy)Device
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | KINETUBE medical Device Receives: Device: insertion of tympanic ventilation tubes (tympanostomy) |
| group B | Active comparator | insertion of tympanic ventilation tubes (tympanostomy) Receives: Device: KINETUBE medical Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study startNov 2013
- Primary completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Otitis Infections in pédiatric PatientsStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LOIC MONDOLONI, Study director, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02038400
- Sponsor's protocol ID
- 2013-A00490-45
- Other IDs
- 2013-17
- Acronym
- KINETUBE
- Status last verified
- Mar 2013
- First submitted
- 28 Nov 2013
- Last updated
- 16 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02038400
- Acronym / sponsor ID
- KINETUBE / 2013-A00490-45
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jul 2016 (estimated)
- First posted
- 16 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Device: insertion of tympanic ventilation tubes (tympanostomy)KINETUBE medical Device |
| group B | Active comparator | Device: KINETUBE medical Deviceinsertion of tympanic ventilation tubes (tympanostomy) |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KINETUBE medical Device | Device | group B |
| insertion of tympanic ventilation tubes (tympanostomy) | Device | group A |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LOIC MONDOLONI study director
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KINETUBE medical Device and insertion of tympanic ventilation tubes (tympanostomy) in people with Chronic Otitis Infections in pédiatric Patients, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of the deficiency of hearing (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2014.