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inVENT-In-Office Study (inVENT-IO)

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ClinicalTrials.gov Identifier: NCT01324271
Recruitment Status : Completed
First Posted : March 29, 2011
Results First Posted : November 25, 2014
Last Update Posted : December 31, 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 (TTDS) for the placement of tympanostomy tubes (TT) under local anesthesia in an office/clinic setting.

Condition or disease Intervention/treatment Phase
Otitis Media Device: Acclarent Tympanostomy Tube Delivery system (TTDS) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 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 (Tula™) Delivery System In-Office
Study Start Date : January 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 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
placement of tympanostomy tube under local anesthesia in office/clinic setting
 Device: Acclarent Tympanostomy Tube Delivery system (TTDS)
placement of tympanostomy tube under local anesthesia
Other Name: Tula™


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Subjects With In-office Tube Placement Procedure Success [ Time Frame: Day 0 ]
    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: the rate was calculated based on the number of subjects achieving Procedure Success out of the total number of enrolled subjects. Only subjects for whom tubes were placed under local anesthesia were evaluated for Procedure Success.

  2. Percentage of Tubes Successfully Placed Using a TTDS Device [ Time Frame: Day 0 ]

    Device (TTDS) success is defined as the successful delivery of a pre-loaded TT tube across the tympanic membrane using the TTDS. Device success will be evaluated per device attempted. Office/clinical subjects only.

    A Device (Type of Unit analyzed) is defined as a TDS attempt. This is not synonymous with "tube." Tube is the outcome of the device use.



Secondary Outcome Measures :
  1. Number of Retained (TTDS-placed) Tubes [ Time Frame: 14 days ]
    Tube retention is the presence of a TT placed successfully by the TTDS device across the tympanic membrane at the two week follow-up visit. Tube retention was confirmed by physician investigator evaluation. N=74 tubes were successfully placed intraprocedurally. Analysis population includes office/clinical subjects only.


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)

Exclusion Criteria:

  • History of sensitivity or reaction to anesthesia chosen for the procedure
  • Significantly atrophic, bimeric, or completely atelectatic tympanic membrane
  • Otitis externa
  • 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): NCT01324271


Locations
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United States, Texas
San Antonio, Texas, United States, 78240
Sponsors and Collaborators
Acclarent
More Information
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Responsible Party: Acclarent
ClinicalTrials.gov Identifier: NCT01324271    
Other Study ID Numbers: CPR005016
First Posted: March 29, 2011    Key Record Dates
Results First Posted: November 25, 2014
Last Update Posted: December 31, 2014
Last Verified: December 2014
Keywords provided by Acclarent:
Tympanostomy tube placement
Additional relevant MeSH terms:
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Otitis Media
Otitis
Ear Diseases
Otorhinolaryngologic Diseases