inVENT-visIOn Study (inVENT-visIOn)

A Clinical Study of the Acclarent Tympanostomy Tube Delivery and Iontophoresis Systems In-Office

The objective of the study is to evaluate the safety and efficacy of the Acclarent Tympanostomy Tube Delivery System (TDS) for the placement of Tympanostomy Tube TT(s) under local anesthesia delivered by iontophoresis in an office/clinic setting.

Study Overview

• Status: Completed
• Conditions: Otitis Media
• Intervention / Treatment: Device: Tympanostomy tube placement (Acclarent iontophoresis device)

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Port St. Lucie, Florida, United States, 34952
      • South Coast Ear, Nose, & Throat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Scheduled to undergo tympanostomy tube insertion
• At least 6 months old
• Behavioral capacity and cooperative temperament to undergo an awake procedure (based on physician judgement)
• No history of sensitivity or reaction to anesthesia chosen for the procedure

Exclusion Criteria:

• Pregnant or lactating females
• Significantly atrophic, bimeric, or completely atelectatic tympanic membrane
• Otitis externa
• Lacerations or abrasions to the external auditory canal or damaged or denuded skin in the auditory canal
• Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane
• Electrically sensitive subjects and subjects with electrically sensitive support systems (pacemakers, defibrillators, etc.)
• Anatomy that precludes sufficient visualization of and access to the tympanic membrane
• Anatomy that necessitates tympanostomy tube placement in the posterior half of the tympanic membrane

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Procedural, Serious and Device-related Adverse Events.	Adverse events which are procedural, serious, and device-related.	Procedure through 2 weeks post-procedure
Device Success	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.	Day 0 (day of procedure)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure Success	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.	Day 0 (day of procedure)
Procedure Tolerability	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.	Day 0 (day of procedure)
Tube Retention	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.	2 weeks post-procedure

Collaborators and Investigators

• Sponsor: Acclarent
• Investigators: Principal Investigator: Jacob W. Zeiders, M.D., South Coast Ear, Nose & Throat

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: September 23, 2011
• First Submitted That Met QC Criteria: September 29, 2011
• First Posted (Estimate): September 30, 2011

Study Record Updates

• Last Update Posted (Estimate): October 1, 2014
• Last Update Submitted That Met QC Criteria: September 20, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Tympanostomy tube placement; iontophoresis
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis; Otitis Media
• Other Study ID Numbers: CPR005022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No