Recurrent Acute Otitis MediaNCT00809601
Study of Different Kinds of Ear Tubes
A study testing Insertion of a specific type of ventilation tube through the tympanic membrane in people with Recurrent Acute Otitis Media and Otitis Media With Effusion With Hearing Impairment, run by Danderyd Hospital at 1 site in Sweden.
Trial summary
There are different kinds of ear tubes that may be inserted into the tympanic membrane to relieve recurrent acute otitis and hearing impairment due to otitis media with effusion. The tubes differ in size, shape and material. Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Recurrent Acute Otitis Media, Otitis Media With Effusion With Hearing Impairment
- What is being tested?
- Insertion of a specific type of ventilation tube through the tympanic membrane
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteSweden
- Study dates
- May 2008to Sep 2015
- 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 1 year to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 1-10 planned for bilateral ventilation tubes
Who cannot join
- Ongoing ear infection
- Previous insertion of ventilation tube
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Study of Transmyringeal Tubes
There are different kinds of ear tubes that may be inserted into the tympanic membrane to relieve recurrent acute otitis and hearing impairment due to otitis media with effusion. The tubes differ in size, shape and material.
No-one knows if there are differences between the different kinds of tubes regarding complications.
The investigators' hypothesis is that there is differences between the different kinds of tubes regarding complications.
To test the investigators' hypothesis, the investigators are about to conduct a randomized controlled study of four kinds of tubes having two different material and two different shapes.
- Being tested
- Insertion of a specific type of ventilation tube through the tympanic membrane
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insertion of a specific type of ventilation tube through the tympanic membraneDevice
The ventilation tubes are tested using one type in one ear and another type as an active comparator in the other ear.
The investigators will test in total 4 different kinds of tubes. Four different combinations of tubes will be tested.
The first combination will test:
"Shepard tube" (double flanged, Fluoroplastic) vs "Donaldson tube" (double flanged, silicone)
The second combination will test:
"Straight tube" (single flanged, Fluoroplastic) vs "Armstrong" (single flanged, silicone)
The third combination will test:
"Armstrong" (single flanged, silicone) vs "Donaldson tube" (double flanged, silicone)
The fourth combination will test:
"Straight tube" (single flanged, Fluoroplastic) vs "Shepard tube" (double flanged, Fluoroplastic)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Device: Insertion of a specific type of ventilation tube through the tympanic membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to complete expulsion of the ventilation tube from the tympanic membrane
Measured: 45 months
Secondary outcomes (6)
Persistent tympanic membrane perforation
Measured: 45 months
Need for tube extraction (pain or infection)
Measured: 45 months
Pain leading to health care contact
Measured: 45 months
Tube related ear infection
Measured: 45 months
Obstruction of the tube
Measured: 45 months
Presence of myringosclerosis
Measured: 45 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2008 (estimated)
- Study startMay 2008
- Primary completionSep 2014 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Acute Otitis MediaStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danderyd Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for clinical research Vastmanland
- Responsible party
- Principal investigator, Magnus von Unge, Danderyd Hospital
- Investigators
- Magnus von Unge, MD, PhD, Principal investigator, ENT-dept Karolinska HospitalJohan Knutsson, MD, Study director, Centre for clinical research Vastmanland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00809601
- Sponsor's protocol ID
- 2008/69-31/3
- Status last verified
- Mar 2013
- First submitted
- 2 May 2008
- Last updated
- 22 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study of Transmyringeal Tubes
- ClinicalTrials.gov ID
- NCT00809601
- Acronym / sponsor ID
- 2008/69-31/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Danderyd HospitalUniversity, hospital or other
- Collaborators
- Centre for clinical research Vastmanland
- Study start
- May 2008
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 17 Dec 2008 (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.
There are different kinds of ear tubes that may be inserted into the tympanic membrane to relieve recurrent acute otitis and hearing impairment due to otitis media with effusion. The tubes differ in size, shape and material.
No-one knows if there are differences between the different kinds of tubes regarding complications.
The investigators' hypothesis is that there is differences between the different kinds of tubes regarding complications.
To test the investigators' hypothesis, the investigators are about to conduct a randomized controlled study of four kinds of tubes having two different material and two different shapes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Insertion of a specific type of ventilation tube through the tympanic membrane |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged 1-10 planned for bilateral ventilation tubes
Key exclusion criteria (2 listed)
- Ongoing ear infection
- Previous insertion of ventilation tube
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 |
|---|---|---|
| Insertion of a specific type of ventilation tube through the tympanic membraneThe ventilation tubes are tested using one type in one ear and another type as an active comparator in the other ear. The investigators will test in total 4 different kinds of tubes. Four different combinations of tubes will be tested. The first combination will test: "Shepard tube" (double flanged, Fluoroplastic) vs "Donaldson tube" (double flanged, silicone) The second combination will test: "Straight tube" (single flanged, Fluoroplastic) vs "Armstrong" (single flanged, silicone) The third combination will test: "Armstrong" (single flanged, silicone) vs "Donaldson tube" (double flanged, silicone) The fourth combination will test: "Straight tube" (single flanged, Fluoroplastic) vs "Shepard tube" (double flanged, Fluoroplastic) | Device | 1 |
Primary outcome
Time to complete expulsion of the ventilation tube from the tympanic membrane
Time frame: 45 months
6 secondary outcomes
Persistent tympanic membrane perforation
Time frame: 45 months
Need for tube extraction (pain or infection)
Time frame: 45 months
Pain leading to health care contact
Time frame: 45 months
Tube related ear infection
Time frame: 45 months
Obstruction of the tube
Time frame: 45 months
Presence of myringosclerosis
Time frame: 45 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2013.
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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.
Magnus von Unge, MD, PhD principal investigator
ENT-dept Karolinska Hospital
Johan Knutsson, MD study director
Centre for clinical research Vastmanland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insertion of a specific type of ventilation tube through the tympanic membrane in people with Recurrent Acute Otitis Media and Otitis Media With Effusion With Hearing Impairment, run by Danderyd Hospital at 1 site in Sweden.
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 1 inclusion and 2 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 22 Mar 2013. 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 Sweden. 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?
Time to complete expulsion of the ventilation tube from the tympanic membrane (time frame: 45 months). 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 22 Mar 2013.