Otitis MediaNCT07029997
Post-Market Clinical Follow-Up Study of the Solo+ Tympanostomy Tube Device
An observational study of Otitis Media and Middle Ear Infections, run by AventaMed DAC at 1 site in Italy.
Trial summary
The purpose of this project is to collect information from the doctor notes about the use of the device, to monitor the tubes after surgery, and collect information from patients and parents/guardians about their views on the procedure. Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Otitis Media, Middle Ear Infections
- What is being tested?
- Solo+ Tympanostomy Tube Device (Solo+ TTD)
- Type of treatment
- Medical device
- How many people
- 160 participants
- Where
- 1 siteItaly
- Study dates
- 21 May 2026to May 2030
- Phase
- Observational
- 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 and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult and paediatric patients (over 6 months) requiring tympanostomy tube placement treated with Solo+ TTD. It is anticipated at least 75% of the study population will be comprised of paediatric patients (under 18 years of age)
Who may be able to join
- Subject and/or Parent/Guardian is able to understand the information document and (depending in the country's legislation) does not object participating or is willing to provide documented informed consent
- Subject was or will be treated, or had a treatment attempted with the study device.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
I.R.C.C.S. Materno Infantile Burlo Garofolo
Trieste, Trieste (TS), 6534137
Clinical Research Coordinator, +390403785863, linda.stefenatti@burlo.trieste.it
About this study
The purpose of this project is to collect information from the doctor notes about the use of the device, to monitor the tubes after surgery, and collect information from patients and parents/guardians about their views on the procedure. Since the device became available in Europe, it is important to collect information from both patients planned for the procedure (prospective) and those who already underwent the procedure (retrospective) to have collect as much data as possible.
Read the detailed description
Patients are being asked to participate in this study because they have been treated, will be treated, or have undergone a treatment attempt with the Solo+ Tympanostomy Tube Device (Solo+ TTD), manufactured by AventaMed. The Solo+ TTD device is a CE marked device designed to deploy ear tubes across the ear drum.
Ear tubes (also known as tympanostomy tubes or ventilation tubes) are predominantly used in treating repeated or long-term middle ear infections, or to treat a build-up of fluid in the middle ear, mostly in children, yet also used for adults. Ear tube insertion allows for air to ventilate the middle ear space and drain fluid from the middle ear.
The Solo+ Tympanostomy Tube Device (Solo+ TTD) is an all-in-one device for the insertion of ear tubes using as little as topical anaesthesia, without requiring general anaesthesia as is the case for other similar devices. The Solo+ TTD is approved for use in children and adults. It is available in Europe and already in use by some clinics and hospitals.
The purpose of this study is to collect information about the use the Solo+ TTD.
- Conditions
- Otitis Media, Middle Ear Infections
- Being tested
- Solo+ Tympanostomy Tube Device (Solo+ TTD)
- Keywords
- ear tubes
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solo+ Tympanostomy Tube Device (Solo+ TTD)Device
insertion of eartubes
| Study group | Role | What they receive |
|---|---|---|
| adults and pedriatic patients who have had eartubes inserted, both prospective and retrospective. | Not described Receives: Device: Solo+ Tympanostomy Tube Device (Solo+ TTD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure Success (Performance)
Percentage of subjects in which the tympanostomy tube is inserted in all indicated ears in a single procedure without the need to schedule a secondary procedure
Measured: 48 months
Functioning Tubes (Performance)
Percentage of ears with a functioning tube (without extrusion and without occlusion) at standard of care follow-up visits until tube extrusion or discharge from standard clinical care
Measured: 48 months
Early Adverse Event (AE) Rates (Safety)
Incidence and nature of device- or procedure-related AEs (per ear and per subject) from the day of the procedure to first follow-up visit post procedure
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start21 May 2026
- Primary completionMay 2030 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AventaMed DAC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07029997
- Sponsor's protocol ID
- CSP004
- Status last verified
- Aug 2026
- First submitted
- 12 Jun 2025
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Clinical Follow-Up Study of the Solo+ Tympanostomy Tube Device
- ClinicalTrials.gov ID
- NCT07029997
- Acronym / sponsor ID
- CSP004
- Conditions
- Otitis Media, Middle Ear Infections
- Keywords
- ear tubes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- AventaMed DACIndustry (pharma, biotech, devices)
- Study start
- 21 May 2026 (actual)
- Primary completion
- May 2030 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 19 Jun 2025 (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 purpose of this project is to collect information from the doctor notes about the use of the device, to monitor the tubes after surgery, and collect information from patients and parents/guardians about their views on the procedure. Since the device became available in Europe, it is important to collect information from both patients planned for the procedure (prospective) and those who already underwent the procedure (retrospective) to have collect as much data as possible.
Detailed description
Patients are being asked to participate in this study because they have been treated, will be treated, or have undergone a treatment attempt with the Solo+ Tympanostomy Tube Device (Solo+ TTD), manufactured by AventaMed. The Solo+ TTD device is a CE marked device designed to deploy ear tubes across the ear drum.
Ear tubes (also known as tympanostomy tubes or ventilation tubes) are predominantly used in treating repeated or long-term middle ear infections, or to treat a build-up of fluid in the middle ear, mostly in children, yet also used for adults. Ear tube insertion allows for air to ventilate the middle ear space and drain fluid from the middle ear.
The Solo+ Tympanostomy Tube Device (Solo+ TTD) is an all-in-one device for the insertion of ear tubes using as little as topical anaesthesia, without requiring general anaesthesia as is the case for other similar devices. The Solo+ TTD is approved for use in children and adults. It is available in Europe and already in use by some clinics and hospitals.
The purpose of this study is to collect information about the use the Solo+ TTD.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adults and pedriatic patients who have had eartubes inserted, both prospective and retrospective. | – | Device: Solo+ Tympanostomy Tube Device (Solo+ TTD) |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult and paediatric patients (over 6 months) requiring tympanostomy tube placement treated with Solo+ TTD. It is anticipated at least 75% of the study population will be comprised of paediatric patients (under 18 years of age)
Key inclusion criteria (2 listed)
- Subject and/or Parent/Guardian is able to understand the information document and (depending in the country's legislation) does not object participating or is willing to provide documented informed consent
- Subject was or will be treated, or had a treatment attempted with the study device.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Solo+ Tympanostomy Tube Device (Solo+ TTD)insertion of eartubes | Device | adults and pedriatic patients who have had eartubes inserted, both prospective and retrospective. |
Primary outcome
Procedure Success (Performance)
Time frame: 48 months
Percentage of subjects in which the tympanostomy tube is inserted in all indicated ears in a single procedure without the need to schedule a secondary procedure
Functioning Tubes (Performance)
Time frame: 48 months
Percentage of ears with a functioning tube (without extrusion and without occlusion) at standard of care follow-up visits until tube extrusion or discharge from standard clinical care
Early Adverse Event (AE) Rates (Safety)
Time frame: 48 months
Incidence and nature of device- or procedure-related AEs (per ear and per subject) from the day of the procedure to first follow-up visit post procedure
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 13 Aug 2026.
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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.
I.R.C.C.S. Materno Infantile Burlo Garofolo
Trieste, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Otitis Media and Middle Ear Infections, run by AventaMed DAC at 1 site in Italy.
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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 13 Aug 2026. 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 Italy. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure Success (Performance) (time frame: 48 months). The study lists 3 primary outcomes in all. 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 13 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.