Evaluation of a new device for ear tube placement in children
Official title: Pivotal In-Office Clinical Study of the Solo+ Tympanostomy Tube Device
Run by AventaMed DAC · NCT05741333 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing a new device to see if it can safely and effectively place ear tubes in children aged 6 months to under 13 years.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Months to 13 Years |
| Sex | All |
| Enrollment | 66 (estimated) |
| Sponsor | AventaMed DAC Industry-sponsored |
| Locations | 7 sites (Alexander City, Alabama and 6 other locations) |
| Trial ID | NCT05741333 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children aged 6 months to under 13 years who require tympanostomy tube insertion.
✕Probably not a fit
Patients with anatomical issues that prevent safe access to the tympanic membrane or those with certain craniofacial abnormalities may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical study aims to assess the safety and effectiveness of the Solo+ Tympanostomy Tube Device (Solo+ TTD) for placing tympanostomy tubes in pediatric patients. It will be conducted at multiple sites and involves a treatment-only approach using topical anesthesia for children aged 6 months to under 13 years. The study will gather data on the device's performance during in-office procedures, focusing on patient outcomes and safety measures.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective method for placing tympanostomy tubes in children, potentially reducing the need for general anesthesia.
How similar studies have gone: While this approach is innovative, similar studies have not been widely reported, indicating that this may be a novel application in the field.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged ≥6 months to \<13 years * Planned tympanostomy tube insertion * Patient is able to commit to the follow-up visits and assessments Exclusion Criteria: * 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
Where it's running
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Southern Head & Neck Surgery
Alexander City, Alabama, United States Recruiting -
North Alabama ENT
Huntsville, Alabama, United States Recruiting -
East Alabama ENT
Opelika, Alabama, United States Recruiting -
Sacramento ENT
Sacramento, California, United States Active not recruiting -
Advanced ENT & Allergy
Louisville, Kentucky, United States Active not recruiting -
Specialty Physician Associates
Bethlehem, Pennsylvania, United States Active not recruiting
Show 1 more location
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South Carolina ENT
Columbia, South Carolina, United States Active not recruiting
Study contacts
- Study coordinator: Keith Jansen
- Email: clinical@aventamed.com
- Phone: +353 21 492 8980
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Parent-led Digital Ear Imaging to Detect Acute Otitis Media
Parents use a digital otoscope at home and AI analyzes the images to see if a child has acute otitis media, aiming to reduce unnecessary doctor visits.
-
CLiKX Tympanostomy Tube Delivery System for Ear Tube Placement
A device is being tested to place ear tubes in both children and adults to see if it can be safely and effectively position the tube during tympanostomy procedures.
-
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We will see if families are comfortable with shorter antibiotic courses and if a Garmin smartwatch can help track symptoms in children aged 4–17 with uncomplicated infections.
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Solo+ Tympanostomy Tube Device: Post-Market Follow-Up
This study tests how well the Solo+ tympanostomy tube device works in people who are getting or have already gotten ear tubes, by collecting doctor notes and patient/guardian experiences after the procedure.
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SWIR Otoscope: Testing a New Way to See Ear Infections in Kids
This study tests whether a short wave infrared (SWIR) otoscope can better identify middle ear fluid in children undergoing tympanostomy tube placement than a standard white light otoscope.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.