CLIKX® Tympanostomy Tube Delivery System for the Placement of Tympanostomy Tubes
Recruiting
N/A
Interventional Study
Otitis Media
Otitis Media Chronic
Otitis Media Effusion
Otitis Media Recurrent
Otitis Media in Children
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 6 Months and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 80 (estimated)
- Sponsor
- ClinQure, Inc. · Research network
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About This Trial
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. These tubes help treat chronic ear fluid (otitis media with effusion) and other conditions where a doctor decides an ear tube is needed.
In this study, surgeons will use the CLiKX device to place an ear tube in the patient's ear. The stu…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Subject is scheduled to undergo tympanostomy tube insertion.
2. Subject is ≥ 6 months old at the time of informed consent.
3. Subject has an ear canal diameter of ≥ 4 mm.
4. Subject is able and willing to provide informed consent or subject's parent/guardian is able and willi…
Contacts