Tympanostomy Tube Placement in Children in the Office (Inova Study)
The objective of the study is to evaluate the safety and efficacy of the Acclarent Tula TDS for the placement of tympanostomy tubes under local anesthesia in an office/clinic setting.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Tympanostomy Tube Placement in Children in the Office (Inova Study)|
- Number of Participants With Procedural, Serious, and Device-Related Adverse Events [ Time Frame: procedure up to 2 weeks post procedure ] [ Designated as safety issue: Yes ]Adverse events which are procedural, serious, and device-related.
- Device Success [ Time Frame: Day 0 (day of procedure) ] [ Designated as safety issue: No ]Device Success is defined as the successful delivery of the tympanostomy tube (TT) across the tympanic membrane (TM) using the Tube Delivery System(TDS). Device Success will be evaluated on a per device basis.
- Procedure Success [ Time Frame: Day 0 (day of procedure) ] [ Designated as safety issue: No ]Procedure Success is defined as the successful placement of any tympanostomy tube in all enrolled ears in a given subject. Procedure Success is determined on a per subject basis.
- Procedure Tolerability [ Time Frame: Day 0 (day of procedure) ] [ Designated as safety issue: No ]
Procedure Tolerability is defined as the proportion of subjects reporting the procedure as tolerable, where tolerable is defined as a score of 0 through 3, using the Wong-Baker FACES pain scale.The Wong-Baker FACES pain scoring system is a scale of 0 to 5, where 0 means 'no hurt', 1 = 'hurts a little bit', 2 = 'hurts little more', 3 = 'hurts even more', 4 = 'hurts whole lot' and 5 = 'hurts worst'. Procedure Tolerability will be determined on a per patient basis, with the patient's score being the average of the scores for the left and right ear if both ears are successfully treated with the Tube Delivery System.
"Tolerability" was defined as an average post-procedure pain score (of treated ears) <= "3"
- Tube Retention [ Time Frame: 2 weeks post procedure ] [ Designated as safety issue: No ]Tube retention is the presence of a tympanostomy tube placed successfully by the Tula TDS device across the tympanic membrane at the two-week follow-up visit.
|Study Start Date:||December 2011|
|Study Completion Date:||April 2012|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
|Experimental: Tube placement group||
Device: Tube Delivery System (TDS)
Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system under local anesthesia in an office/clinic setting
Other Name: Tula TDS
Please refer to this study by its ClinicalTrials.gov identifier: NCT01496287
|United States, Florida|
|South Coast Ear, Nose & Throat|
|Port St. Lucie, Florida, United States, 34952|
|Principal Investigator:||Jacob W Zeiders, M.D.||South Coast Ear, Nose & Throat|