Evaluation of a new device for ear tube placement in children
Pivotal In-Office Clinical Study of the Solo+ Tympanostomy Tube Device
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 6 Months to 13 Years |
| Sex | All |
| Sponsor | AventaMed DAC Industry-sponsored |
| Locations | 7 sites (Alexander City, Alabama and 6 other locations) |
| Trial ID | NCT05741333 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 6 months to under 13 years who require tympanostomy tube insertion.
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.
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 performed: While this approach is innovative, similar studies have not been widely reported, indicating that this may be a novel application in the field.
Eligibility criteria
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 this trial is running
Alexander City, Alabama and 6 other locations
- 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)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.