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Tympanostomy Tube Placement in Children in the Office (Inova Study)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Acclarent
ClinicalTrials.gov Identifier:
NCT01496287
First received: December 16, 2011
Last updated: November 4, 2014
Last verified: November 2014
Results First Received: June 26, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Otitis Media
Intervention: Device: Tube Delivery System (TDS)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Tube Placement Group Tube Delivery System (Tula): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device

Participant Flow:   Overall Study
    Tube Placement Group  
STARTED     70  
COMPLETED     64  
NOT COMPLETED     6  
Lost to Follow-up                 1  
Incomplete anesthesia                 5  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Tube Placement Group Tube Delivery System (Tula): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system under local anesthesia in an office/clinic setting

Baseline Measures
    Tube Placement Group  
Number of Participants  
[units: participants]
  70  
Age  
[units: years]
Mean ± Standard Deviation
  7.0  ± 3.9  
Gender  
[units: participants]
 
Female     36  
Male     34  
Race/Ethnicity, Customized  
[units: participants]
 
African American or Black     5  
Asian     1  
White     47  
Other or Unknown     17  
Region of Enrollment  
[units: participants]
 
United States     70  



  Outcome Measures
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1.  Primary:   Number of Participants With Procedural, Serious, and Device-Related Adverse Events   [ Time Frame: procedure up to 2 weeks post procedure ]

2.  Primary:   Device Success   [ Time Frame: Day 0 (day of procedure) ]

3.  Secondary:   Procedure Success   [ Time Frame: Day 0 (day of procedure) ]

4.  Secondary:   Procedure Tolerability   [ Time Frame: Day 0 (day of procedure) ]

5.  Secondary:   Tube Retention   [ Time Frame: 2 weeks post procedure ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Director of Clinical Research
Organization: Acclarent, Inc.
phone: 650-687-5888
e-mail: lenglan1@its.jnj.com


No publications provided


Responsible Party: Acclarent
ClinicalTrials.gov Identifier: NCT01496287     History of Changes
Other Study ID Numbers: CPR005027
Study First Received: December 16, 2011
Results First Received: June 26, 2014
Last Updated: November 4, 2014
Health Authority: United States: Institutional Review Board