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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the Solo+ Tympanostomy Tube Device (Solo+ TTD) to evaluate its safety and effectiveness for children needing ear tube surgery. Ear tubes are tiny cylinders placed in the eardrum to help with frequent ear infections or fluid buildup. The trial seeks children aged 6 months to under 13 years who are already scheduled for this procedure. Participants must be willing to attend follow-up visits to monitor their progress. As an unphased trial, this study offers a unique opportunity for participants to contribute to medical advancements in pediatric ear care.

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 prior data suggests that the Solo+ Tympanostomy Tube Device is safe for ear tube insertion in children?

Research shows that the Solo+ Tympanostomy Tube Device (Solo+ TTD) is generally safe and well-tolerated in children. Studies indicate that this device effectively places ear tubes to help with ear infections in kids. It consistently works well across different age groups, performing reliably without causing unexpected issues.

The device carries a CE mark, indicating it meets safety standards in Europe, which supports its safety. The available data reports no major adverse events. Overall, the Solo+ TTD appears to be a safe option for children who need ear tubes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for ear infections that often involve surgical procedures using reusable instruments, the Solo+ Tympanostomy Tube Device (Solo+ TTD) is unique because it is a disposable tool specifically designed to inserta tympanostomy tube directly into the tympanic membrane. This delivery method aims to simplify the procedure, potentially reducing the risk of infection associated with reusable tools. Researchers are excited about this device because it could streamline the process, making it safer and more efficient for patients needing ear tube placement.

What evidence suggests that the Solo+ Tympanostomy Tube Device is effective for ear infections?

Research has shown that the Solo+ Tympanostomy Tube Device (Solo+ TTD), which participants in this trial will receive, effectively places ear tubes in children. One study found that 88.6% of the tubes remained in place and functioned well after 12 months. The device requires only a small amount of anesthesia, making the procedure less invasive. Follow-up studies confirm its effectiveness for children of various ages. Overall, the Solo+ TTD appears promising in addressing ear infections by ensuring proper placement and function of the tubes. ^{1 5 6 7 8}

Who Is on the Research Team?

Matija Daniel

Principal Investigator

Queen's Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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-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]

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41022022/

A single step tympanostomy tube (TT) Delivery device Through 12-months follow-up, 20 % of TT were extruded (9/44 ears) and 88.6 % of present TT (31/35 ears) were functioning. Conclusion: The Solo + ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07029997

Post-Market Clinical Follow-Up Study of the Solo+ ... The Solo+ Tympanostomy Tube Device (Solo+ TTD) is an all-in-one device for the insertion of ear tubes using as little as topical anaesthesia, ...

3. karlstorz.com karlstorz.com/us/en/aventamed-receives-expanded-indication-for-soloplus-tympanostomy-tube-device.htm

AventaMed, a KARL STORZ Company, Receives ... The Solo+ Tympanostomy Tube Device demonstrated consistent, reliable performance across pediatric age groups, with strong follow-up outcomes.

4. ctv.veeva.com ctv.veeva.com/study/in-office-clinical-study-of-the-solo-ttd

In-Office Clinical Study of the Solo+ TTD - ClinicalTrials.Veeva The objective of this study is to evaluate the safety and effectiveness of the Solo+ Tympanostomy Tube Device (Solo+ TTD) for the placement ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05741333

NCT05741333 | In-Office Clinical Study of the Solo+ TTD The objective of this study is to evaluate the safety and effectiveness of the Solo+ Tympanostomy Tube Device (Solo+ TTD) for the placement of tympanostomy ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07029997

Post-Market Clinical Follow-Up Study of the Solo+ ... The Solo+ TTD device is a CE marked device designed to deploy ear tubes across the ear drum. Ear tubes (also known as tympanostomy tubes or ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf25/K250256.pdf

April 28, 2025 AventaMed DAC Keith Jansen President and ... The Solo+ Tympanostomy Tube Device (Solo+ TTD) is a single use, sterile, “all-in-one” surgical instrument that rapidly places a tympanostomy ...

8. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05741333/in-office-clinical-study-of-the-solo-ttd

In-Office Clinical Study of the Solo+ TTD The objective of this study is to evaluate the safety and effectiveness of the Solo+ Tympanostomy Tube Device (Solo+ TTD) for the placement of tympanostomy ...