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Tympanostomy Tube Device

Solo+ Tympanostomy Tube Device for Ear Infections

N/A

Waitlist Available

Research Sponsored by AventaMed DAC

Eligibility Criteria Checklist

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

Must have

Listed for bilateral tympanostomy tube insertion

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trial is testing a new device for placing tympanostomy tubes in children. The goal is to see if it is safe and effective.

Who is the study for?

This trial is for children who need tubes placed in both ears to treat ear infections. They must have a clear hearing test and eardrum movement test (audiometry and tympanometry) before the study. Kids with very narrow ear canals, stiff eardrums, or certain ear shapes that make it hard to see or safely reach the eardrum aren't eligible.Check my eligibility

What is being tested?

The Solo+ Tympanostomy Tube Device is being tested for its safety and how well it works when placing grommets into kids' ears during surgery for ear infections. The device aims to improve this common procedure.See study design

What are the potential side effects?

While specific side effects are not listed, typical risks of tympanostomy tube placement include bleeding, infection, persistent drainage from the ear, scarring of the eardrum, or issues with the tubes such as blockage or falling out.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for ear tube surgery in both ears.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of Adverse Events

Successful delivery of the tympanostomy tube by the Solo+ Tympanostomy Tube Device

Trial Design

1Treatment groups

Experimental Treatment

Group I: Solo+ Tympanostomy Tube DeviceExperimental Treatment1 Intervention

The Solo+ Tympanostomy Tube Device is a disposable surgical tool designed to deliver a tympanostomy tube (grommet) into the tympanic membrane of patients undergoing a tympanostomy tube placement procedure

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

AventaMed DACLead Sponsor

3 Previous Clinical Trials

113 Total Patients Enrolled

Matija DanielStudy ChairQueen's Medical Center

3 Previous Clinical Trials

113 Total Patients Enrolled

Media Library

Solo+ Tympanostomy Tube Device (Tympanostomy Tube Device) Clinical Trial Eligibility Overview. Trial Name: NCT04148417 — N/A

Ear Infection Research Study Groups: Solo+ Tympanostomy Tube Device

Ear Infection Clinical Trial 2023: Solo+ Tympanostomy Tube Device Highlights & Side Effects. Trial Name: NCT04148417 — N/A

Solo+ Tympanostomy Tube Device (Tympanostomy Tube Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04148417 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities for subjects to participate in this research?

"It appears that, based on information posted to clinicaltrials.gov, this medical trial is no longer recruiting participants - the listing was first shared in February 2021 and last updated on July 19th 2022. However, 18 additional trials are presently accepting patients for enrollment into their programs."

Answered by AI

Is the age threshold for this experiment restricted to those under 55 years of age?

"According to the trial's parameters, applicants aged between 6 Months and 15 years old are able to apply. Additionally, there exist 17 trials for participants younger than 18 and 3 separate studies targeting patients over 65."

Answered by AI

To which demographic are the study's enrollment criteria applicable?

"27 individuals between 6 months and 15 years old, who have been listed for bilateral tympanostomy tube insertion due to otitis media, are able to enrol in this research study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Clinical Study of the Solo+ Tympanostomy Tube Device

2021. "Clinical Study of the Solo+ Tympanostomy Tube Device". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04148417.