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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
Sponsor:
Information provided by (Responsible Party):
Acclarent

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Otitis Media Device: Tympanostomy tube placement (Acclarent iontophoresis device) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

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


Locations
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United States, Florida
South Coast Ear, Nose, & Throat
Port St. Lucie, Florida, United States, 34952
Sponsors and Collaborators
Acclarent
Investigators
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Principal Investigator: Jacob W. Zeiders, M.D. South Coast Ear, Nose & Throat
More Information
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Responsible Party: Acclarent
ClinicalTrials.gov Identifier: NCT01444391    
Other Study ID Numbers: CPR005022
First Posted: September 30, 2011    Key Record Dates
Results First Posted: September 19, 2014
Last Update Posted: October 1, 2014
Last Verified: September 2014
Keywords provided by Acclarent:
Tympanostomy tube placement
iontophoresis
Additional relevant MeSH terms:
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Otitis Media
Otitis
Ear Diseases
Otorhinolaryngologic Diseases