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

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ClinicalTrials.gov Identifier: NCT01496287
Recruitment Status : Completed
First Posted : December 21, 2011
Results First Posted : July 24, 2014
Last Update Posted : November 6, 2014
Sponsor:
Information provided by (Responsible Party):
Acclarent

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Otitis Media
Intervention: Device: Tube Delivery System (TDS)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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

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.
No text entered.

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 
Overall Participants Analyzed 
[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

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

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

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

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Acclarent
ClinicalTrials.gov Identifier: NCT01496287     History of Changes
Other Study ID Numbers: CPR005027
First Submitted: December 16, 2011
First Posted: December 21, 2011
Results First Submitted: June 26, 2014
Results First Posted: July 24, 2014
Last Update Posted: November 6, 2014