Otitis Media in ChildrenNCT06191562
Posterior vs. Anterior Tympanostomy Tube Placement
A study testing Tympanostomy tube in people with Otitis Media in Children and Chronic Otitis Media With Effusion, run by David Chi, MD at 2 sites in United States.
Trial summary
The goal of this randomized clinical trial is to compare the results of ear tube placement in two different parts of the ear drum. The ear drum can be divided into four parts (called quadrants). Ear tubes are usually placed in one section of the ear drum, called the anterior-inferior quadrant. Read more about this study
- Who is it for?
- Ages 6 months to 14 years
- Conditions the study is for
- Otitis Media in Children, Chronic Otitis Media With Effusion, Recurrent Acute Otitis Media
- What is being tested?
- Tympanostomy tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 386 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Feb 2024to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 months to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ages 6 months -14 years
- Bilateral tympanostomy tube placement
- First tympanostomy tubes placement
- Indication for tympanostomy tube placement is otitis media
Who cannot join
- Undergoing tympanostomy tube placement for indication other than otitis media
- Receiving tubes other than Armstrong grommet.
- Genetic disorder that impacts the craniofacial structure, immune system, or mucosal secretions such as Downs syndrome, Stickler syndrome, Treacher Collins syndrome, other genetic disorder associated with craniofacial anomalies, Severe Combined Immunodeficiency disorder, Cystic Fibrosis, or Primary Ciliary Dyskinesia
- Patients with craniofacial abnormalities other than plagiocephaly or submucous cleft palate (SMCP)
- Caregivers who cannot speak, read, or write in English proficiently
- Prior or current otologic surgery other than tympanostomy tube placement
Show all 12Show fewer
- On systemic corticosteroids at the time of enrollment
- Immunodeficiency (acquired or congenital)
- Current retraction, cholesteatoma, or middle ear mass
- Atresia
- Sensorineural hearing loss
- Known ossicular chain anomaly
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
UPMC Children's Hospital of Pittsburgh North
Sewickley, Pennsylvania, 15143
About this study
Official title: Randomized Clinical Trial of Post-operative Outcomes Following Posterior Versus Anterior Tympanostomy Tube Placement
The goal of this randomized clinical trial is to compare the results of ear tube placement in two different parts of the ear drum. The ear drum can be divided into four parts (called quadrants). Ear tubes are usually placed in one section of the ear drum, called the anterior-inferior quadrant. However, tubes can also be placed in another section, called the posterior-inferior quadrant. Ear tubes usually fall out of the ear drum on their own. In most patients, the hole in the ear drum where the tube used to be closes on its own. Sometimes (in about 2% of patients), the hole does not close on its own and might need surgery. We want to study ear tube placement in the posterior-inferior quadrant because surgery to repair a hole in the eardrum is easier in this location.
For this study, children will receive an ear tube in the usual location (anterior-inferior quadrant) in one ear and the new location (posterior-inferior quadrant) in the other ear. Researchers will determine which ear has the new location using random assignment (like flipping a coin). Researchers will collect information about hearing tests, whether there is ear drainage (otorrhea), if the tube is blocked (occluded), and how the ear drum looks for up to 37 months after tube placement. Participants will answer study questions at 2-12 weeks and 6, 12, 18, 24, 30, and 36 months after surgery. These questions will ask about whether tubes have fallen out of the ear drum, whether there is a hole in the ear drum, whether there has been drainage from the ear or other ear symptoms, and whether there have been any visits to the doctor for ear problems.
Researchers will use this information to compare ears with anterior-inferior tube placement and ears with posterior-inferior tube placement to see if there are differences in common complications following tube placement.
Read the detailed description
The tympanic membrane can be divided into quadrants: posterior superior, anterior superior, posterior inferior, and anterior inferior. Traditional training dictates that tympanostomy tubes should be placed in the anterior-inferior quadrant, with the thought that this would lead to longer indwelling time in the tympanic membrane, avoidance of damage to the ossicular chain, and prevention of hearing loss due to residual perforation over the round window following tympanostomy tube extrusion. However, more recent work has challenged these assumptions. Notably, there is a 2-16% risk of chronic perforation following tympanostomy tube extrusion, with a proposed annual incidence of more than 40,000 post-tympanostomy tube perforations in the United States each year. While perforations in the posterior tympanic membrane can often be repaired using transcanal approaches, anterior perforations are more likely to require more invasive postauricular or endoaural approaches or canalplasty. To our knowledge, there are no studies reporting outcomes following tympanostomy tube placement in the posterior-inferior quadrant. If this study demonstrates no difference in hearing, tube indwelling time, and sequelae following posterior-inferior placement compared with anterior-inferior, it would allow otolaryngologists greater flexibility to consider patient characteristics such as factors placing them at increased risk for perforation or anatomy of the auditory canal when selecting the section of tympanic membrane in which to place tubes.
Upon completion of screening, patients will be randomized using a random number generator in order to have an equal distribution of left and right ears with tympanostomy tubes placed in the anterior and posterior quadrants. Consented patients will receive an ear tube in the usual location (anterior-inferior) in one ear and a new location (posterior-inferior) in the other ear during surgery. Follow-up will include standard-of-care post-operative visits and may be completed at 2-12 weeks and 5-7 months. Clinicians will examine the child's ears and determine whether otorrhea and occlusion are present. During the visit, audiologists may conduct standard of care ear-specific pure tone average, air-bone gap, and sound field audiometry. At these follow-up visits, otolaryngology providers will complete a form describing the status of the tympanic membrane. This will add <1 minute to the visit. Caregivers will also complete a form asking about the status of their child's tympanostomy tubes and any ear problems their child has experienced since surgery. This will take <5 minutes to complete. Results of audiology testing will be collected from the electronic medical record. Additional follow-up will include administration of the caregiver questions via phone, mail, or REDCap email at 12, 18, 24, 30, and 36 months. If the child has other follow-up clinic visits prior to 37 months post-surgery, the provider form will be completed again during these visits. Further research activities will include viewing medical charts of the included subjects.
- Conditions
- Otitis Media in Children, Chronic Otitis Media With Effusion, Recurrent Acute Otitis Media
- Being tested
- Tympanostomy tube
- Keywords
- Middle ear ventilation, Otitis media
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tympanostomy tubeDevice
Also called Myringotomy with tubes; pressure equalization tubes; ventilation tubes
Participants will receive an ear tube in the usual location (anterior-inferior) in one ear and a new location (posterior-inferior) in the other ear during surgery.
| Study group | Role | What they receive |
|---|---|---|
| Posterior Tympanostomy Tube Left | Experimental | Patients in whom the left ear is randomized to receive a tympanostomy tube in the posterior-inferior quadrant (new location). Receives: Device: Tympanostomy tube |
| Posterior Tympanostomy Tube Right | Experimental | Patients in whom the right ear is randomized to receive a tympanostomy tube in the posterior-inferior quadrant (new location). Receives: Device: Tympanostomy tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perforation
Percentage of ears with persistent (>3 month) perforation of the tympanic membrane
Measured: Within 36 months +/- 30 days following tympanostomy tube placement
Secondary outcomes (14)
Parent-reported otorrhea at 2-12 weeks
Percentage of ears with ear drainage most days (67-100%), many days (33-67%), some days (1-33%) or no days (0)
Measured: 2-12 weeks following tympanostomy tube placement
Parent-reported otorrhea at 6 months
Percentage of ears with ear drainage most days (67-100%), many days (33-67%), some days (1-33%) or no days (0)
Measured: 6 months±30 days following tympanostomy tube placement
Provider-observed tube occlusion at 2-12 weeks
Percentage of ears with tubes occluded
Measured: 2-12 weeks following tympanostomy tube placement
Provider-observed tube occlusion at 6 months
Percentage of ears with tubes occluded
Measured: 6 months±30 days following tympanostomy tube placement
Provider-observed tympanostomy tubes in place and patent at 2-12 weeks
Percentage of ears with tympanostomy tubes in place and patent
Measured: 2-12 weeks following tympanostomy tube placement
Provider-observed tympanostomy tubes in place and patent at 6 months
Percentage of ears with tympanostomy tubes in place and patent
Measured: 6 months±30 days following tympanostomy tube placement
Retained tubes requiring surgical intervention
Percentage of ears requiring surgical tympanostomy tube removal
Measured: Within 36 months +/- 30 days following tympanostomy tube placement
Perforation requiring surgical intervention
Percentage of ears with surgical repair of perforation
Measured: Within 36 months +/- 30 days following tympanostomy tube placement
Atrophy or retraction at tube site
Percentage of ears with atrophy or retraction at tube site
Measured: Within 36 months +/- 30 days following tympanostomy tube placement
Cholesteatoma
Percentage of ears with cholesteatoma
Measured: Within 36 months +/- 30 days following tympanostomy tube placement
Hearing loss
Percentage of ears with pure tone average >20 dB or absent otoacoustic emissions
Measured: Within 36 months +/- 30 days following tympanostomy tube placement
Tube indwelling time before extrusion
Months from tympanostomy tube placement to extrusion estimated from parent-report and provider observations
Measured: Within 36 months +/- 30 days following tympanostomy tube placement
Ability to see through lumen and assess tube patency at 2-12 weeks
Percentage of ears in which the otolaryngology provider is able to see through lumen and assess tube patency
Measured: 2-12 weeks following tympanostomy tube placement
Ability to see through lumen and assess tube patency at 6 months
Percentage of ears in which the otolaryngology provider is able to see through lumen and assess tube patency
Measured: 6 months±30 days following tympanostomy tube placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start29 Feb 2024
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Otitis Media in ChildrenStudies 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
- Model description
- Experimental, randomized control trial with no placebo
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 386 participants (estimated)
Sponsor and investigators
- Lead sponsor
- David Chi, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David Chi, MD, University of Pittsburgh
- Investigators
- David H Chi, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06191562
- Sponsor's protocol ID
- STUDY22120108
- Status last verified
- Feb 2026
- First submitted
- 19 Dec 2023
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie the results reported in a publication may be shared, after de-identification.
Publications
ALBERTI PW. EPITHELIAL MIGRATION ON THE TYMPANIC MEMBRANE. J Laryngol Otol. 1964 Sep;78:808-30. doi: 10.1017/s0022215100062800. No abstract available.
PubMed 14205963O'Donoghue GM. The kinetics of epithelial cells in relation to ventilating tubes. Acta Otolaryngol. 1984 Jul-Aug;98(1-2):105-9. doi: 10.3109/00016488409107541.
PubMed 6380208Gibb AG, Mackenzie IJ. The extrusion rate of grommets. Otolaryngol Head Neck Surg. 1985 Dec;93(6):695-9. doi: 10.1177/019459988509300601.
PubMed 3937089Kivekas I, Poe D. Is there an optimal location for tympanostomy tube placement? Laryngoscope. 2015 Jul;125(7):1513-4. doi: 10.1002/lary.25127. Epub 2015 Jan 13. No abstract available.
PubMed 25582620Mehta RP, Rosowski JJ, Voss SE, O'Neil E, Merchant SN. Determinants of hearing loss in perforations of the tympanic membrane. Otol Neurotol. 2006 Feb;27(2):136-43. doi: 10.1097/01.mao.0000176177.17636.53.
PubMed 16436981Stinson WD. Reparative processes in the membrana tympani: some interested manifestations. Arch Otolaryngol. 1936; 24(5): 600-605. doi:10.1001/archotol.1936.00640050613006.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Post-operative Outcomes Following Posterior Versus Anterior Tympanostomy Tube Placement
- ClinicalTrials.gov ID
- NCT06191562
- Acronym / sponsor ID
- STUDY22120108
- Conditions
- Otitis Media in Children, Chronic Otitis Media With Effusion, Recurrent Acute Otitis Media
- Keywords
- Middle ear ventilation, Otitis media
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 386 participants (estimated)
- Lead sponsor
- David Chi, MDUniversity, hospital or other
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 5 Jan 2024 (actual)
- 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.
The goal of this randomized clinical trial is to compare the results of ear tube placement in two different parts of the ear drum. The ear drum can be divided into four parts (called quadrants). Ear tubes are usually placed in one section of the ear drum, called the anterior-inferior quadrant. However, tubes can also be placed in another section, called the posterior-inferior quadrant. Ear tubes usually fall out of the ear drum on their own. In most patients, the hole in the ear drum where the tube used to be closes on its own. Sometimes (in about 2% of patients), the hole does not close on its own and might need surgery. We want to study ear tube placement in the posterior-inferior quadrant because surgery to repair a hole in the eardrum is easier in this location.
For this study, children will receive an ear tube in the usual location (anterior-inferior quadrant) in one ear and the new location (posterior-inferior quadrant) in the other ear. Researchers will determine which ear has the new location using random assignment (like flipping a coin). Researchers will collect information about hearing tests, whether there is ear drainage (otorrhea), if the tube is blocked (occluded), and how the ear drum looks for up to 37 months after tube placement. Participants will answer study questions at 2-12 weeks and 6, 12, 18, 24, 30, and 36 months after surgery. These questions will ask about whether tubes have fallen out of the ear drum, whether there is a hole in the ear drum, whether there has been drainage from the ear or other ear symptoms, and whether there have been any visits to the doctor for ear problems.
Researchers will use this information to compare ears with anterior-inferior tube placement and ears with posterior-inferior tube placement to see if there are differences in common complications following tube placement.
Detailed description
The tympanic membrane can be divided into quadrants: posterior superior, anterior superior, posterior inferior, and anterior inferior. Traditional training dictates that tympanostomy tubes should be placed in the anterior-inferior quadrant, with the thought that this would lead to longer indwelling time in the tympanic membrane, avoidance of damage to the ossicular chain, and prevention of hearing loss due to residual perforation over the round window following tympanostomy tube extrusion. However, more recent work has challenged these assumptions. Notably, there is a 2-16% risk of chronic perforation following tympanostomy tube extrusion, with a proposed annual incidence of more than 40,000 post-tympanostomy tube perforations in the United States each year. While perforations in the posterior tympanic membrane can often be repaired using transcanal approaches, anterior perforations are more likely to require more invasive postauricular or endoaural approaches or canalplasty. To our knowledge, there are no studies reporting outcomes following tympanostomy tube placement in the posterior-inferior quadrant. If this study demonstrates no difference in hearing, tube indwelling time, and sequelae following posterior-inferior placement compared with anterior-inferior, it would allow otolaryngologists greater flexibility to consider patient characteristics such as factors placing them at increased risk for perforation or anatomy of the auditory canal when selecting the section of tympanic membrane in which to place tubes.
Upon completion of screening, patients will be randomized using a random number generator in order to have an equal distribution of left and right ears with tympanostomy tubes placed in the anterior and posterior quadrants. Consented patients will receive an ear tube in the usual location (anterior-inferior) in one ear and a new location (posterior-inferior) in the other ear during surgery. Follow-up will include standard-of-care post-operative visits and may be completed at 2-12 weeks and 5-7 months. Clinicians will examine the child's ears and determine whether otorrhea and occlusion are present. During the visit, audiologists may conduct standard of care ear-specific pure tone average, air-bone gap, and sound field audiometry. At these follow-up visits, otolaryngology providers will complete a form describing the status of the tympanic membrane. This will add <1 minute to the visit. Caregivers will also complete a form asking about the status of their child's tympanostomy tubes and any ear problems their child has experienced since surgery. This will take <5 minutes to complete. Results of audiology testing will be collected from the electronic medical record. Additional follow-up will include administration of the caregiver questions via phone, mail, or REDCap email at 12, 18, 24, 30, and 36 months. If the child has other follow-up clinic visits prior to 37 months post-surgery, the provider form will be completed again during these visits. Further research activities will include viewing medical charts of the included subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Experimental, randomized control trial with no placebo
| Arm | Type | Receives |
|---|---|---|
| Posterior Tympanostomy Tube Left | Experimental | Device: Tympanostomy tubePatients in whom the left ear is randomized to receive a tympanostomy tube in the posterior-inferior quadrant (new location). |
| Posterior Tympanostomy Tube Right | Experimental | Device: Tympanostomy tubePatients in whom the right ear is randomized to receive a tympanostomy tube in the posterior-inferior quadrant (new location). |
Who may qualify
- Ages
- 6 months to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Ages 6 months -14 years
- Bilateral tympanostomy tube placement
- First tympanostomy tubes placement
- Indication for tympanostomy tube placement is otitis media
Key exclusion criteria (12 listed)
- Undergoing tympanostomy tube placement for indication other than otitis media
- Receiving tubes other than Armstrong grommet.
- Genetic disorder that impacts the craniofacial structure, immune system, or mucosal secretions such as Downs syndrome, Stickler syndrome, Treacher Collins syndrome, other genetic disorder associated with craniofacial anomalies, Severe Combined Immunodeficiency disorder, Cystic Fibrosis, or Primary Ciliary Dyskinesia
- Patients with craniofacial abnormalities other than plagiocephaly or submucous cleft palate (SMCP)
- Caregivers who cannot speak, read, or write in English proficiently
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 |
|---|---|---|
| Tympanostomy tubeAlso: Myringotomy with tubes; pressure equalization tubes; ventilation tubesParticipants will receive an ear tube in the usual location (anterior-inferior) in one ear and a new location (posterior-inferior) in the other ear during surgery. | Device | Posterior Tympanostomy Tube Left, Posterior Tympanostomy Tube Right |
Primary outcome
Perforation
Time frame: Within 36 months +/- 30 days following tympanostomy tube placement
Percentage of ears with persistent (>3 month) perforation of the tympanic membrane
14 secondary outcomes
Parent-reported otorrhea at 2-12 weeks
Time frame: 2-12 weeks following tympanostomy tube placement
Parent-reported otorrhea at 6 months
Time frame: 6 months±30 days following tympanostomy tube placement
Provider-observed tube occlusion at 2-12 weeks
Time frame: 2-12 weeks following tympanostomy tube placement
Provider-observed tube occlusion at 6 months
Time frame: 6 months±30 days following tympanostomy tube placement
Provider-observed tympanostomy tubes in place and patent at 2-12 weeks
Time frame: 2-12 weeks following tympanostomy tube placement
Provider-observed tympanostomy tubes in place and patent at 6 months
Time frame: 6 months±30 days following tympanostomy tube placement
Retained tubes requiring surgical intervention
Time frame: Within 36 months +/- 30 days following tympanostomy tube placement
Perforation requiring surgical intervention
Time frame: Within 36 months +/- 30 days following tympanostomy tube placement
Atrophy or retraction at tube site
Time frame: Within 36 months +/- 30 days following tympanostomy tube placement
Cholesteatoma
Time frame: Within 36 months +/- 30 days following tympanostomy tube placement
Hearing loss
Time frame: Within 36 months +/- 30 days following tympanostomy tube placement
Tube indwelling time before extrusion
Time frame: Within 36 months +/- 30 days following tympanostomy tube placement
Ability to see through lumen and assess tube patency at 2-12 weeks
Time frame: 2-12 weeks following tympanostomy tube placement
Ability to see through lumen and assess tube patency at 6 months
Time frame: 6 months±30 days following tympanostomy tube placement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Background: PubMed 14205963ALBERTI PW. EPITHELIAL MIGRATION ON THE TYMPANIC MEMBRANE. J Laryngol Otol. 1964 Sep;78:808-30. doi: 10.1017/s0022215100062800. No abstract available.
- Background: PubMed 6380208O'Donoghue GM. The kinetics of epithelial cells in relation to ventilating tubes. Acta Otolaryngol. 1984 Jul-Aug;98(1-2):105-9. doi: 10.3109/00016488409107541.
- Background: PubMed 3937089Gibb AG, Mackenzie IJ. The extrusion rate of grommets. Otolaryngol Head Neck Surg. 1985 Dec;93(6):695-9. doi: 10.1177/019459988509300601.
- Background: PubMed 25582620Kivekas I, Poe D. Is there an optimal location for tympanostomy tube placement? Laryngoscope. 2015 Jul;125(7):1513-4. doi: 10.1002/lary.25127. Epub 2015 Jan 13. No abstract available.
- Background: PubMed 16436981Mehta RP, Rosowski JJ, Voss SE, O'Neil E, Merchant SN. Determinants of hearing loss in perforations of the tympanic membrane. Otol Neurotol. 2006 Feb;27(2):136-43. doi: 10.1097/01.mao.0000176177.17636.53.
- BackgroundStinson WD. Reparative processes in the membrana tympani: some interested manifestations. Arch Otolaryngol. 1936; 24(5): 600-605. doi:10.1001/archotol.1936.00640050613006.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie the results reported in a publication may be shared, after de-identification.
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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.
David H Chi, MD principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tympanostomy tube in people with Otitis Media in Children and Chronic Otitis Media With Effusion, run by David Chi, MD at 2 sites in United States.
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 4 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Perforation (time frame: Within 36 months +/- 30 days following tympanostomy tube placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06191562, which also lists 6 linked publications.
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 20 Feb 2026.