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Evaluation of the Tympanostomy Tube Delivery System (inVENT-OR)

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ClinicalTrials.gov Identifier: NCT01202578
Recruitment Status : Completed
First Posted : September 16, 2010
Results First Posted : July 11, 2014
Last Update Posted : July 11, 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
Conditions: Otitis Media With Effusion
Acute Otitis Media
Intervention: Device: tympanostomy tube

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Eligible subjects presenting to the clinical study site for whom tympanostomy tube insertion was recommended were offered the opportunity to participate in the study by study investigators.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Tympanostomy Tube Placement Using the Tube Delivery System No text entered.

Participant Flow:   Overall Study
    Tympanostomy Tube Placement Using the Tube Delivery System
STARTED   53 
COMPLETED   53 
NOT COMPLETED   0 



  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
Tympanostomy Tube Placement Using the Tube Delivery System No text entered.

Baseline Measures
   Tympanostomy Tube Placement Using the Tube Delivery System 
Overall Participants Analyzed 
[Units: Participants]
 53 
Age 
[Units: Years]
Mean (Standard Deviation)
 2.68  (2.49) 
Age, Customized 
[Units: Participants]
 
<=5 years   47 
>5 years   6 
Gender 
[Units: Participants]
 
Female   22 
Male   31 
Region of Enrollment 
[Units: Participants]
 
United States   53 


  Outcome Measures

1.  Primary:   Safety of Tympanostomy Tube (TT) Delivery System   [ Time Frame: 7 days ]

2.  Primary:   Device Success   [ Time Frame: 0 days ]

3.  Secondary:   Proportion of Subjects With Procedure Success   [ Time Frame: 0 days ]

4.  Secondary:   Tube Retention   [ Time Frame: 7 days ]


  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
No text entered.


  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



Responsible Party: Acclarent
ClinicalTrials.gov Identifier: NCT01202578     History of Changes
Other Study ID Numbers: CPR005013
First Submitted: September 13, 2010
First Posted: September 16, 2010
Results First Submitted: May 7, 2014
Results First Posted: July 11, 2014
Last Update Posted: July 11, 2014