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Study of the ENTact Septal Staple System for Tissue Approximation During Septoplasty

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: NCT00740480
Recruitment Status : Completed
First Posted : August 25, 2008
Results First Posted : August 21, 2009
Last Update Posted : August 25, 2009
Sponsor:
Information provided by:
ENTrigue Surgical, Inc.

Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Nasal Septum

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Chart reviews and patient contact in clinic. Recruitment period from July 2008 to January 2009.

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
Septal Stapler Group Adult population (ages 18-65) with clinically significant nasal septum deviation.

Participant Flow:   Overall Study
    Septal Stapler Group
STARTED   25 
COMPLETED   23 
NOT COMPLETED   2 
Adverse Event                1 
Physician Decision                1 



  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
Septal Stapler Group Adult population (ages 18-65) with clinically significant nasal septum deviation.

Baseline Measures
   Septal Stapler Group 
Overall Participants Analyzed 
[Units: Participants]
 25 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   25 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 39.9  (13.7) 
Gender 
[Units: Participants]
 
Female   13 
Male   12 
Region of Enrollment 
[Units: Participants]
 
United States   25 


  Outcome Measures

1.  Primary:   Coaptation (Tissue Approximation)   [ Time Frame: One week post surgery ]

2.  Secondary:   Tissue Reaction to Implant   [ Time Frame: One week post surgery ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Gabriele Niederauer, PhD
Organization: ENTrigue Surgical, Inc.
phone: 210-298-6398 ext 6336
e-mail: gabi.niederauer@entriguesurgical.com



Responsible Party: Gabriele Niederauer, Ph.D./Vice President, Research and Development, ENTrigue Surgical, Inc.
ClinicalTrials.gov Identifier: NCT00740480     History of Changes
Other Study ID Numbers: CSA 2008-01
First Submitted: August 21, 2008
First Posted: August 25, 2008
Results First Submitted: July 15, 2009
Results First Posted: August 21, 2009
Last Update Posted: August 25, 2009