Ear Tube Insertion Device for Ear Infections

(VENTY Trial)

Recruiting at 6 trial locations

Overseen By Keith Jansen

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: AventaMed DAC

Disqualifiers: Narrow ear canals, Congenital abnormalities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Intra-operative

66 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 5 6 7 8}

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. ^{4 9 10 11 12}

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

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.

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 Overview The 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

Group I: Solo+ Tympanostomy Tube Device (Solo+ TTD) Experimental Treatment 1 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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tympanostomy Tube Innovation: Advances in Device Material, Design, and Office-Based Technology. Whelan, RL., Maguire, RC.[2022]

The current literature on tympanostomy tube insertion in an office setting is insufficient to provide clear recommendations on the best practices or long-term outcomes, highlighting a need for more research in this area.

Clinicians should make decisions about in-office tube insertion based on their experience, ability to communicate with caregivers, and the expected cooperation level of the child, rather than relying on standardized guidelines due to the lack of robust evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Office Insertion of Tympanostomy Tubes and the Role of Automated Insertion Devices. Rosenfeld, RM., Tunkel, DE., Schwartz, SR.[2022]

In a study of 183 children who underwent tympanostomy tube (TT) placement, 21.9% required a second TT insertion, with a mean retention time of 12.13 months for the first tube.

Key risk factors for needing a second TT included a shorter retention time and recurrent acute otitis media (RAOM), highlighting the importance of monitoring these children after the first tube is removed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictive factors for repeated tympanostomy tube placement in children. Lombo, C., Costa, R., Martins, M., et al.[2022]

A single-dose intratympanic administration of OTO-201 significantly reduced the incidence of treatment failures, including otorrhea, in children undergoing tympanostomy tube placement compared to those receiving TTP alone, with odds ratios indicating a strong protective effect.

The use of OTO-201 was found to be safe, with no serious drug-related adverse events reported, and it did not negatively impact hearing or cause tube occlusion, suggesting it is a viable option for managing middle ear effusions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Intratympanic Ciprofloxacin Otic Suspension in Children With Middle Ear Effusion Undergoing Tympanostomy Tube Placement: Two Randomized Clinical Trials. Mair, EA., Park, AH., Don, D., et al.[2018]

In 2014, 8.6% of children in the U.S. underwent tympanostomy tube placement (TTP), with a higher prevalence in males (9.6%) compared to females (7.5%).

Among children under 2 years, 25% with frequent ear infections (FEI) received TTP, indicating a strong association between FEI and the need for TTP, especially in younger children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidemiology of Pediatric Tympanostomy Tube Placement in the United States. Bhattacharyya, N., Shay, SG.[2020]

In a study of 193,880 children in Ontario who underwent tympanostomy tube (TT) placement, 28.58% required multiple procedures, with younger age at first TT being a significant risk factor for needing more surgeries.

Risk factors such as male sex, certain medical conditions (like asthma and gastrointestinal disease), and socioeconomic status were linked to a higher likelihood of multiple TT procedures, while adenoidectomy or tonsillectomy performed at the time of the first TT placement reduced this risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical predictors of multiple tympanostomy tube placements in Ontario children. Beyea, JA., Nguyen, P., Hall, SF.[2018]

In a study analyzing 48 tympanostomy tubes (TTs) from 30 children, biofilms were found on all TTs, particularly at the perpendicular junctions and internal lumen, indicating these areas are prone to bacterial colonization.

Children with post-tympanostomy tube otorrhea (PTTO) had significantly more biofilm colonies on their TTs compared to those without PTTO, suggesting a link between biofilm presence and chronic ear complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biofilm distribution on tympanostomy tubes: An ex vivo descriptive study. Habashi, N., Marom, T., Steinberg, D., et al.[2021]

In a study of 75 children followed for up to 38 months after tympanostomy tube (TT) insertion, otorrhea was the most common complication, occurring in 47.3% of ears, while other complications included tympanosclerosis (23.3%) and retractions (39.7%).

The study found that TT insertion combined with adenoidectomy led to fewer episodes of otorrhea, and younger children at the time of initial tube placement were more likely to need a second set of tubes, indicating that age and surgical strategy can influence outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tympanostomy tube sequelae in children with otitis media with effusion: a three-year follow-up study. Pereira, MB., Pereira, DR., Costa, SS.[2022]

In a study of 245 ears in 144 children, there was no significant difference in the overall incidence of otorrhea between silicon tubes (ST) and gilded silver tubes (GT), but ST was linked to a higher rate of infections with Pseudomonas aeruginosa.

The study suggests that GT should be preferred during mastoidectomy procedures, as none of the ears with GT developed postoperative otorrhea, highlighting the importance of water protection in preventing infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Infection frequency and type of bacteria after tympanostomy tube drainage in childhood: gilded-silver tubes versus silicone tubes]. Schmäl, F., Nieschalk, M., Delank, KW., et al.[2020]

In-office placement of tympanostomy tubes (TT) in awake children using a novel single-pass device was highly successful, with a 98.7% success rate across 229 children, demonstrating a safe alternative to traditional surgery under general anesthesia.

The procedure was well tolerated, with only two minor adverse events reported, and it offers a less invasive option for families concerned about the risks and costs associated with operating room procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In-office insertion tympanostomy tubes in children using single-pass device. Truitt, TO., Kosko, JR., Nimmons, GL., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Association of tympanostomy tubes with future assistive hearing devices-a population based study. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Treatment of chronic otitis media with effusion: results of tympanostomy tubes. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Tympanostomy Tube Innovation: Advances in Device Material, Design, and Office-Based Technology. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Office Insertion of Tympanostomy Tubes and the Role of Automated Insertion Devices. [2022]

5. Spain pubmed.ncbi.nlm.nih.gov

Predictive factors for repeated tympanostomy tube placement in children. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Intratympanic Ciprofloxacin Otic Suspension in Children With Middle Ear Effusion Undergoing Tympanostomy Tube Placement: Two Randomized Clinical Trials. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Epidemiology of Pediatric Tympanostomy Tube Placement in the United States. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Clinical predictors of multiple tympanostomy tube placements in Ontario children. [2018]

9. Ireland pubmed.ncbi.nlm.nih.gov

Biofilm distribution on tympanostomy tubes: An ex vivo descriptive study. [2021]

10. Brazil pubmed.ncbi.nlm.nih.gov

Tympanostomy tube sequelae in children with otitis media with effusion: a three-year follow-up study. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

[Infection frequency and type of bacteria after tympanostomy tube drainage in childhood: gilded-silver tubes versus silicone tubes]. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

In-office insertion tympanostomy tubes in children using single-pass device. [2023]