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New treatment option for Otitis Media
Official title CLIKX® Tympanostomy Tube Delivery System for the Placement of Tympanostomy Tubes
ClinicalTrials.gov ID: NCT07625657
What this study is testing
- What it's testing
- This study looks at the safety and performance of the CLiKX device. The device is used to place ear tubes (also called ventilation tubes) in children and adults.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 and older
You may be able to join if
- Subject is scheduled to undergo tympanostomy tube insertion.
- Subject is ≥ 6 months old at the time of informed consent.
- Subject has an ear canal diameter of ≥ 4 mm.
- Subject is able and willing to provide informed consent or subject's parent/guardian is able and willing to provide informed consent and subject is...
You likely can't join if
- people who are pregnant as confirmed by the institution's standard pre- surgery practice.
- people with known adverse reaction to anesthesia.
- people with atrophic, dimeric, severely thinned and scarred, severely thickened, severely retracted, atelectatic or perforated tympanic membrane.
- people with otitis externa.
- people with active acute otitis media.
- people with an ear canal diameter \< 4 mm.
See the full eligibility criteria
- Subject is scheduled to undergo tympanostomy tube insertion.
- Subject is ≥ 6 months old at the time of informed consent.
- Subject has an ear canal diameter of ≥ 4 mm.
- Subject is able and willing to provide informed consent or subject's parent/guardian is able and willing to provide informed consent and subject is able and willing to provide assent as age appropriate (age 7 years to...
- people who are pregnant as confirmed by the institution's standard pre- surgery practice.
- people with known adverse reaction to anesthesia.
- people with atrophic, dimeric, severely thinned and scarred, severely thickened, severely retracted, atelectatic or perforated tympanic membrane.
- people with otitis externa.
- people with active acute otitis media.
- people with an ear canal diameter \< 4 mm.
- Ear drums that are overly vertical or horizontal
- people with an anatomy that precludes visualization and access to the tympanic membrane, in the opinion of the investigator.
- people with any condition that, in the opinion of the investigator, may place the subject at greater risk.
- people with suspected middle ear tumors or vascular lesions.
- people diagnosed with acute sensorial hearing loss
- people with a history of surgery involving the ear drum.
- people with hemotympanum.
- Subject is not able or willing to comply with study procedures and follow-up requirements, in the opinion of the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Louisville, Kentucky, United States
- Mesquite, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 months and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Louisville, Kentucky, United States; Mesquite, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.