CLiKX® Tympanostomy Tube Delivery System for Ear Tube Placement
This study is testing a new device called CLiKX® Tympanostomy Tube Delivery System. This device helps surgeons place ear tubes (tympanostomy tubes) in children and adults who have chronic ear fluid (otitis media with effusion) or other ear conditions. The study will check if the CLiKX device can safely and effectively place the ear tube in the correct position. Surgeons will use the CLiKX device to insert an ear tube, first trying with no or local anesthesia, and then using mild sedation or general anesthesia if needed. The study will also monitor for any side effects during the procedure. This trial is for people aged 6 months and older who are scheduled to have ear tubes inserted and have an ear canal diameter of at least 4 mm. The status of this study is currently unclear.
- Study design
- This is a single-arm study, meaning all participants will receive the CLiKX device. It plans to enroll 80 participants to evaluate the safety and effectiveness of the device.
- What's involved
- You would have a baseline visit, the ear tube procedure, a visit at discharge, and a follow-up visit 30 days after the procedure.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety and other assessments through 30 days post-procedure.
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CLIKX® Tympanostomy Tube Delivery System for the Placement of Tympanostomy Tubes
At a glance
Conditions
Where it's being run
2 sites across 2 statesWho to contact
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What this trial measures
- Effectiveness of C-TTDS for tympanostomy tube placementAt time of procedure (first or second attempt)
Effectiveness will be determined by success at the end of each ear tube procedure. Effectiveness is defined as the successful incision in the tympanic membrane and delivery of tympanostomy tube across the tympanic membrane in the proper position after a maximum of 2 insertion attempts per indicated ear. An insertion attempt is defined as an incision in the tympanic membrane by the C-TTDS
- Safety of C-TTDS for tympanostomy tube placementAt time of procedure (first or second attempt)
Safety will be assessed by incidence, severity and relatedness of device related adverse events occurring during the overall procedure.