What side effects are associated with this type of intervention?

The common treatments for ear infections, particularly involving tympanostomy tubes, include the placement of the tubes and the use of antibiotics. The side effects of tympanostomy tube placement can include ear discharge (otorrhea), scarring of the eardrum (tympanosclerosis), and, rarely, persistent perforation of the eardrum. Antibiotic treatments can cause allergic reactions, gastrointestinal disturbances, and, in some cases, antibiotic resistance.

What prior FDA approvals exist?

The FDA has approved several treatments for ear infections, particularly those involving the use of tympanostomy tubes to ventilate the middle ear. Traditional tympanostomy tubes and advanced devices like the Solo+ Tympanostomy Tube Device are used to prevent fluid accumulation and infections. Additionally, antibiotics such as amoxicillin/clavulanate and azithromycin are commonly approved for treating acute otitis media, aiming to reduce infection and inflammation.

What other types of research exist?

Promising alternatives to the Solo+ Tympanostomy Tube Device for ear infection patients include: 1) The Tula System, which allows for in-office tube placement without general anesthesia. 2) The use of drug-eluting tympanostomy tubes that release antibiotics or anti-inflammatory agents to reduce infection and inflammation. 3) Non-surgical options like balloon dilation of the Eustachian tube, which can improve middle ear ventilation and reduce the need for tube placement.

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Device

Ear Tube Insertion Device for Ear Infections (VENTY Trial)

N/A

Recruiting

Research Sponsored by AventaMed DAC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not specified, but may include typical risks associated with tympanostomy procedures such as pain, infection, or hearing issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Procedure Success

Rate of Adverse Events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Tympanostomy tubes, also known as ear tubes, are commonly used to treat chronic ear infections by ventilating the middle ear and preventing fluid accumulation. The mechanism involves creating a small opening in the eardrum to insert the tube, which allows air to enter the middle ear and fluid to drain out, reducing the risk of infection and improving hearing. This is particularly important for patients with recurrent or chronic otitis media, as it helps to alleviate symptoms, prevent complications, and reduce the need for repeated antibiotic treatments.

Clinical approach to treatment of otitis media.