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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 belowSelect...
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
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
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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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Doctors can't see both of my eardrums properly due to my anatomy.You were born with abnormalities in your face or head.I cannot safely access both of my eardrums due to my anatomy.I have narrow ear canals.I am scheduled for ear tube surgery in both ears.
Research Study Groups:
This trial has the following groups:- Group 1: Solo+ Tympanostomy Tube Device
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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