inVENT-visIOn Study (inVENT-visIOn)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|Otitis Media||Device: Tympanostomy tube placement (Acclarent iontophoresis device)|
|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|
|Primary Completion Date :||May 2012|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|