inVENT-visIOn Study (inVENT-visIOn)
|ClinicalTrials.gov Identifier: NCT01444391|
Recruitment Status : Completed
First Posted : September 30, 2011
Results First Posted : September 19, 2014
Last Update Posted : October 1, 2014
|Condition or disease||Intervention/treatment||Phase|
|Otitis Media||Device: Tympanostomy tube placement (Acclarent iontophoresis device)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Clinical Study of the Acclarent Tympanostomy Tube Delivery and Iontophoresis Systems In-Office|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||June 2012|
|Experimental: Tympanostomy Tube Placement||
Device: Tympanostomy tube placement (Acclarent iontophoresis device)
Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
- Number of Subjects With Procedural, Serious and Device-related Adverse Events. [ Time Frame: Procedure through 2 weeks post-procedure ]Adverse events which are procedural, serious, and device-related.
- Device Success [ Time Frame: Day 0 (day of procedure) ]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) ]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) ]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.
- Tube Retention [ Time Frame: 2 weeks post-procedure ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01444391
|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|