66 Participants Needed

Ear Tube Insertion Device for Ear Infections

(VENTY Trial)

Recruiting at 6 trial locations
KJ
Overseen ByKeith Jansen
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: AventaMed DAC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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

MD

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

Patient is able to commit to the follow-up visits and assessments
I am scheduled for ear tube surgery.
I am between 6 months and 12 years old.

Exclusion Criteria

No baseline audiometry or tympanometry
Patient unable to remain still or is unsuitable for protective stabilization to undergo an in-office procedure
I have narrow ear canals.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo tympanostomy tube placement using the Solo+ Tympanostomy Tube Device with topical anesthesia

Intra-operative

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Treatment Details

Interventions

  • Solo+ Tympanostomy Tube Device (Solo+ TTD)
Trial OverviewThe study is testing the Solo+ Tympanostomy Tube Device (Solo+ TTD) for safety and effectiveness in placing ear tubes during a standard procedure in pediatric patients.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Solo+ Tympanostomy Tube Device (Solo+ TTD)Experimental Treatment1 Intervention
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.

Solo+ Tympanostomy Tube Device (Solo+ TTD) is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Solo+ TTD for:
  • Recurrent acute otitis media (AOM)
  • Chronic otitis media with effusion (OME)
  • Persistent middle ear infections
🇪🇺
Approved in European Union as Solo+ TTD for:
  • 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

Trials
4
Recruited
140+

Findings from Research

Children who underwent tympanostomy tube (TT) placement had a significantly higher risk of needing rehabilitative hearing devices compared to those who did not have the procedure, with odds ratios indicating a 4.53 times higher risk than the No-TT group and 10.81 times higher than the Control group.
The study, which analyzed data from over 1.3 million children in Ontario, suggests a concerning link between ear tube placement and long-term hearing loss, highlighting the need for further research to understand the implications of this common surgery.
Association of tympanostomy tubes with future assistive hearing devices-a population based study.Beyea, JA., Cooke, B., Rosen, E., et al.[2021]
Tympanostomy tubes are an effective treatment for chronic secretory otitis media in children, showing significant benefits in time to first recurrence compared to myringotomy alone, based on a randomized clinical trial.
The study supports the continued use of tympanostomy tubes as a primary surgical option when medical therapy is insufficient, as they help improve hearing and address anatomical issues in the tympanum.
Treatment of chronic otitis media with effusion: results of tympanostomy tubes.Gates, GA., Wachtendorf, C., Hearne, EM., et al.[2019]
New single-use devices for tympanostomy tube insertion could reduce operating room time and allow for procedures under moderate anesthesia instead of general anesthesia, making the process safer for children.
Innovations in tympanostomy tube materials and designs may improve drug delivery, reduce tube blockage, and even allow tubes to dissolve on command, although these technologies are still in early testing phases.
Tympanostomy Tube Innovation: Advances in Device Material, Design, and Office-Based Technology.Whelan, RL., Maguire, RC.[2022]

References

Association of tympanostomy tubes with future assistive hearing devices-a population based study. [2021]
Treatment of chronic otitis media with effusion: results of tympanostomy tubes. [2019]
Tympanostomy Tube Innovation: Advances in Device Material, Design, and Office-Based Technology. [2022]
Office Insertion of Tympanostomy Tubes and the Role of Automated Insertion Devices. [2022]
Predictive factors for repeated tympanostomy tube placement in children. [2022]
Safety and Efficacy of Intratympanic Ciprofloxacin Otic Suspension in Children With Middle Ear Effusion Undergoing Tympanostomy Tube Placement: Two Randomized Clinical Trials. [2018]
Epidemiology of Pediatric Tympanostomy Tube Placement in the United States. [2020]
Clinical predictors of multiple tympanostomy tube placements in Ontario children. [2018]
Biofilm distribution on tympanostomy tubes: An ex vivo descriptive study. [2021]
Tympanostomy tube sequelae in children with otitis media with effusion: a three-year follow-up study. [2022]
[Infection frequency and type of bacteria after tympanostomy tube drainage in childhood: gilded-silver tubes versus silicone tubes]. [2020]
12.United Statespubmed.ncbi.nlm.nih.gov
In-office insertion tympanostomy tubes in children using single-pass device. [2023]