Ear InfectionVENTYNCT05741333
In-Office Clinical Study of the Solo+ TTD
A study testing Solo+ Tympanostomy Tube Device (Solo+ TTD) in people with Ear Infection and Otitis Media, run by AventaMed DAC at 7 sites in United States.
Trial summary
The objective of this study is to evaluate the safety and effectiveness of the Solo+ Tympanostomy Tube Device (Solo+ TTD) for the placement of tympanostomy tubes in paediatric patients undergoing a tympanostomy procedure. Read more about this study
- Who is it for?
- Ages 6 months to 13 years
- Conditions the study is for
- Ear Infection, Otitis Media
- What is being tested?
- Solo+ Tympanostomy Tube Device (Solo+ TTD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 7 sitesUnited States
- Study dates
- 30 Mar 2023to Mar 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 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients aged ≥6 months to <13 years
- Planned tympanostomy tube insertion
- Patient is able to commit to the follow-up visits and assessments
Who cannot join
- Anatomy that precludes sufficient visualization of the tympanic membrane
- Anatomy that precludes safe access to the tympanic membrane and safe use of the Solo+ TTD
- Narrow ear canals
- Congenital or craniofacial abnormalities affecting the ear
- No baseline audiometry or tympanometry
- Familial history of insensitivity to anesthetic components
- Patient unable to remain still or is unsuitable for protective stabilization to undergo an in-office procedure
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Southern Head & Neck Surgery
Alexander City, Alabama, 35010
Specialty Physician Associates
Bethlehem, Pennsylvania, 18017
South Carolina ENT
Columbia, South Carolina, 29203
North Alabama ENT
Huntsville, Alabama, 35801
Advanced ENT & Allergy
Louisville, Kentucky, 40220
East Alabama ENT
Opelika, Alabama, 36801
Sacramento ENT
Sacramento, California, 95661
About this study
Official title: Pivotal In-Office Clinical Study of the Solo+ Tympanostomy Tube Device
The objective of this study is to evaluate the safety and effectiveness of the Solo+ Tympanostomy Tube Device (Solo+ TTD) for the placement of tympanostomy tubes in paediatric patients undergoing a tympanostomy procedure.
Read the detailed description
The study will be a multi-site, prospective, treatment-only study to gather safety and effectiveness data on the use of the Solo+ TTD in-office with topical anesthesia in children aged ≥6 months to <13 years.
- Conditions
- Ear Infection, Otitis Media
- Being tested
- Solo+ Tympanostomy Tube Device (Solo+ TTD)
- Medical subject headings
- Otitis, 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
The Solo+ TTD is intended to deliver a tympanostomy tube through the tympanic membrane of a patient.
| Study group | Role | What they receive |
|---|---|---|
| Solo+ Tympanostomy Tube Device (Solo+ TTD) | Experimental | The Solo+ TTD is a disposable surgical tool designed to deliver a tympanostomy tube into the tympanic membrane of patients undergoing a tympanostomy tube placement procedure. 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
Percentage of subjects in which the Solo+ TTD tympanostomy tube is inserted in all indicated ears
Measured: Intra-operative
Rate of Adverse Events
Incidence and nature of device- or procedure-related adverse events
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start30 Mar 2023
- Primary completion19 Mar 2026
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ear InfectionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AventaMed DAC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matija Daniel, Study chair, Queen's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05741333
- Sponsor's protocol ID
- CSP003
- Acronym
- VENTY
- Status last verified
- Nov 2026
- First submitted
- 14 Feb 2023
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal In-Office Clinical Study of the Solo+ Tympanostomy Tube Device
- ClinicalTrials.gov ID
- NCT05741333
- Acronym / sponsor ID
- VENTY / CSP003
- Conditions
- Ear Infection, Otitis Media
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- AventaMed DACIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 19 Mar 2026 (actual)
- Study completion
- Mar 2028 (estimated)
- First posted
- 23 Feb 2023 (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 objective of this study is to evaluate the safety and effectiveness of the Solo+ Tympanostomy Tube Device (Solo+ TTD) for the placement of tympanostomy tubes in paediatric patients undergoing a tympanostomy procedure.
Detailed description
The study will be a multi-site, prospective, treatment-only study to gather safety and effectiveness data on the use of the Solo+ TTD in-office with topical anesthesia in children aged ≥6 months to <13 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Solo+ Tympanostomy Tube Device (Solo+ TTD) | Experimental | Device: Solo+ Tympanostomy Tube Device (Solo+ TTD)The Solo+ TTD is a disposable surgical tool designed to deliver a tympanostomy tube into the tympanic membrane of patients undergoing a tympanostomy tube placement procedure. |
Who may qualify
- Ages
- 6 months to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients aged ≥6 months to <13 years
- Planned tympanostomy tube insertion
- Patient is able to commit to the follow-up visits and assessments
Key exclusion criteria (7 listed)
- Anatomy that precludes sufficient visualization of the tympanic membrane
- Anatomy that precludes safe access to the tympanic membrane and safe use of the Solo+ TTD
- Narrow ear canals
- Congenital or craniofacial abnormalities affecting the ear
- No baseline audiometry or tympanometry
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)The Solo+ TTD is intended to deliver a tympanostomy tube through the tympanic membrane of a patient. | Device | Solo+ Tympanostomy Tube Device (Solo+ TTD) |
Primary outcome
Procedure Success
Time frame: Intra-operative
Percentage of subjects in which the Solo+ TTD tympanostomy tube is inserted in all indicated ears
Rate of Adverse Events
Time frame: 24 months
Incidence and nature of device- or procedure-related adverse events
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 4 Nov 2026.
- Individual participant dataSharing planned: No
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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.
Matija Daniel study chair
Queen's Medical Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Solo+ Tympanostomy Tube Device (Solo+ TTD) in people with Ear Infection and Otitis Media, run by AventaMed DAC at 7 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 3 inclusion and 7 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 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Procedure Success (time frame: Intra-operative). The study lists 2 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 4 Nov 2026.