Ear Tube Insertion Device for Ear Infections
(VENTY Trial)
Trial Summary
What is the purpose of this trial?
This trial is testing a device that helps doctors put small tubes in children's eardrums. It targets kids who need this procedure to prevent ear infections. The device works by making it easier to place the tubes, which help drain fluid from the ear.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the Solo+ Tympanostomy Tube Device treatment for ear infections?
The use of tympanostomy tubes, like the Solo+ Tympanostomy Tube Device, is a common treatment for chronic ear infections in children, helping to improve hearing by providing drainage and ventilation to the middle ear. A study found that tympanostomy tubes are effective in reducing the time to first recurrence of ear infections compared to other treatments, supporting their continued use in managing chronic ear infections.12345
Is the Solo+ Tympanostomy Tube Device safe for humans?
The available research does not provide specific safety data for the Solo+ Tympanostomy Tube Device, but tympanostomy tube placement is a common procedure in children. While the long-term effects are not fully known, it is widely used, suggesting a general acceptance of its safety in medical practice.15678
How is the Solo+ Tympanostomy Tube Device treatment different from other treatments for ear infections?
The Solo+ Tympanostomy Tube Device is unique because it allows for the insertion of ear tubes in an office setting without the need for general anesthesia, which is typically required for such procedures in children. This makes the process less invasive and potentially more convenient for both patients and healthcare providers.49101112
Research Team
Matija Daniel
Principal Investigator
Queen's Medical Center
Eligibility Criteria
This trial is for children aged 6 months to under 13 years who need ear tubes inserted due to infections. They must be able to attend follow-up visits.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo tympanostomy tube placement using the Solo+ Tympanostomy Tube Device with topical anesthesia
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Solo+ Tympanostomy Tube Device (Solo+ TTD)
Solo+ Tympanostomy Tube Device (Solo+ TTD) is already approved in United States, European Union for the following indications:
- Recurrent acute otitis media (AOM)
- Chronic otitis media with effusion (OME)
- Persistent middle ear infections
- Recurrent acute otitis media (AOM)
- Chronic otitis media with effusion (OME)
- Persistent middle ear infections
Find a Clinic Near You
Who Is Running the Clinical Trial?
AventaMed DAC
Lead Sponsor