Ear InfectionNCT04148417
Clinical Study of the Solo+ Tympanostomy Tube Device
A study testing Solo+ Tympanostomy Tube Device in people with Ear Infection and Otitis Media, run by AventaMed DAC at 2 sites in United States.
Trial summary
The objective of this study is to evaluate the safety and performance of the Solo+ Tympanostomy Tube Device for the placement of tympanostomy tubes (grommets) in paediatric patients undergoing a tympanostomy procedure Read more about this study
- Who is it for?
- Ages 6 months to 15 years
- Conditions the study is for
- Ear Infection, Otitis Media
- What is being tested?
- Solo+ Tympanostomy Tube Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Feb 2021to Sep 2024
- 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 6 months to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Listed for bilateral tympanostomy tube insertion
Who cannot join
- Anatomy that precludes sufficient visualisation of both the left and right eardrum
- Narrow ear canals
- Anatomy that precludes safe access to both the left and right eardrum
- Membrane >25% sclerosis
- Congenital or craniofacial abnormalities
- No available baseline audiometry and tympanometry
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
The objective of this study is to evaluate the safety and performance of the Solo+ Tympanostomy Tube Device for the placement of tympanostomy tubes (grommets) in paediatric patients undergoing a tympanostomy procedure
Read the detailed description
The study will be a multi-site, prospective, treatment-only study of the Solo+ Tympanostomy Tube Device. Patients will already have a scheduled tympanostomy procedure.
- Conditions
- Ear Infection, Otitis Media
- Being tested
- Solo+ Tympanostomy Tube Device
- 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 DeviceDevice
The Solo+ Tympanostomy Tube Device is intended to deliver a tympanostomy tube through the tympanic membrane of a patient during a tympanostomy procedure
| Study group | Role | What they receive |
|---|---|---|
| Solo+ Tympanostomy Tube Device | Experimental | The Solo+ Tympanostomy Tube Device is a disposable surgical tool designed to deliver a tympanostomy tube (grommet) into the tympanic membrane of patients undergoing a tympanostomy tube placement procedure Receives: Device: Solo+ Tympanostomy Tube Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful delivery of the tympanostomy tube by the Solo+ Tympanostomy Tube Device
The number of ears in which the Solo Tympanostomy Tube Device tube is placed
Measured: Intra-operative
Rate of Adverse Events
The number and type of 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 posted1 Nov 2019
- Study start9 Feb 2021
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (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
- 27 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
- NCT04148417
- Sponsor's protocol ID
- CSP002
- Status last verified
- Jan 2024
- First submitted
- 30 Oct 2019
- Last updated
- 24 Jan 2024
- 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 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of the Solo+ Tympanostomy Tube Device
- ClinicalTrials.gov ID
- NCT04148417
- Acronym / sponsor ID
- CSP002
- Conditions
- Ear Infection, Otitis Media
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- AventaMed DACIndustry (pharma, biotech, devices)
- Study start
- 9 Feb 2021 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 1 Nov 2019 (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 performance of the Solo+ Tympanostomy Tube Device for the placement of tympanostomy tubes (grommets) in paediatric patients undergoing a tympanostomy procedure
Detailed description
The study will be a multi-site, prospective, treatment-only study of the Solo+ Tympanostomy Tube Device. Patients will already have a scheduled tympanostomy procedure.
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 | Experimental | Device: Solo+ Tympanostomy Tube DeviceThe Solo+ Tympanostomy Tube Device is a disposable surgical tool designed to deliver a tympanostomy tube (grommet) into the tympanic membrane of patients undergoing a tympanostomy tube placement procedure |
Who may qualify
- Ages
- 6 months to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Listed for bilateral tympanostomy tube insertion
Key exclusion criteria (6 listed)
- Anatomy that precludes sufficient visualisation of both the left and right eardrum
- Narrow ear canals
- Anatomy that precludes safe access to both the left and right eardrum
- Membrane >25% sclerosis
- Congenital or craniofacial abnormalities
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 DeviceThe Solo+ Tympanostomy Tube Device is intended to deliver a tympanostomy tube through the tympanic membrane of a patient during a tympanostomy procedure | Device | Solo+ Tympanostomy Tube Device |
Primary outcome
Successful delivery of the tympanostomy tube by the Solo+ Tympanostomy Tube Device
Time frame: Intra-operative
The number of ears in which the Solo Tympanostomy Tube Device tube is placed
Rate of Adverse Events
Time frame: 24 months
The number and type of Adverse Events
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- 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
2 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 in people with Ear Infection and Otitis Media, run by AventaMed DAC 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 1 inclusion and 6 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 24 Jan 2024. 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?
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?
Successful delivery of the tympanostomy tube by the Solo+ Tympanostomy Tube Device (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 24 Jan 2024; AzTrials last refreshed its copy on 8 Nov 2026.