inVENT-visIOn Study (inVENT-visIOn)

This study has been completed.
Information provided by (Responsible Party):
Acclarent Identifier:
First received: September 23, 2011
Last updated: September 20, 2014
Last verified: September 2014
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.

Condition Intervention
Otitis Media
Device: Tympanostomy tube placement (Acclarent iontophoresis device)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Clinical Study of the Acclarent Tympanostomy Tube Delivery and Iontophoresis Systems In-Office

Further study details as provided by Acclarent:

Primary Outcome Measures:
  • Number of Subjects With Procedural, Serious and Device-related Adverse Events. [ Time Frame: Procedure through 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.

Secondary Outcome Measures:
  • 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.

  • 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.

Enrollment: 42
Study Start Date: October 2011
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01444391

United States, Florida
South Coast Ear, Nose, & Throat
Port St. Lucie, Florida, United States, 34952
Sponsors and Collaborators
Principal Investigator: Jacob W. Zeiders, M.D. South Coast Ear, Nose & Throat
  More Information

Responsible Party: Acclarent Identifier: NCT01444391     History of Changes
Other Study ID Numbers: CPR005022 
Study First Received: September 23, 2011
Results First Received: June 26, 2014
Last Updated: September 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Acclarent:
Tympanostomy tube placement

Additional relevant MeSH terms:
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases processed this record on May 26, 2016