Study of Polyester Implants for the Treatment of External Nasal Valve Collapse (NVC)

This study has been terminated.
(Strategic Business Decision)
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Xomed, Inc.
ClinicalTrials.gov Identifier:
NCT00729781
First received: August 5, 2008
Last updated: December 1, 2011
Last verified: December 2011
Results First Received: August 23, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Nasal Alar Collapse, Bilateral
Intervention: Device: Polyester Implants

  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
No text entered.

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
Polyester Implants There was one arm for this study. All subjects in this study received the investigational polyethylene terephthalate (PET) implants after enrollment in the original study. Subjects who could be reached and consented were enrolled in the long-term follow-up study, which was initiated to collect adverse events. See the detailed description for procedure information.

Participant Flow for 2 periods

Period 1:   Original Study
    Polyester Implants  
STARTED     45  
COMPLETED     45  
NOT COMPLETED     0  

Period 2:   Long-term Follow-up Study
    Polyester Implants  
STARTED     42 [1]
COMPLETED     42 [2]
NOT COMPLETED     0  
[1] Enrollment in the long-term follow-up required contact and a new Informed Consent.
[2] All subjects completed the original study, but 3 did not consent to enroll in the follow-up study.



  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.
No text entered.

Reporting Groups
  Description
Polyester Implants There was one arm for this study. All subjects in this study received the investigational polyethylene terephthalate (PET) implants after enrollment in the original study. Subjects who could be reached and consented were enrolled in the long-term follow-up study, which was initiated to collect adverse events. See the detailed description for procedure information.

Baseline Measures
    Polyester Implants  
Number of Participants  
[units: participants]
  45  
Age  
[units: years]
Mean ± Standard Deviation
 
All subjects     45.0  ± 12.2  
Gender  
[units: participants]
 
Female     23  
Male     22  
Race/Ethnicity, Customized  
[units: participants]
 
White     43  
Hispanic     2  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Functional Improvement   [ Time Frame: 12 weeks after implantation ]

2.  Primary:   Cosmetic Improvement   [ Time Frame: 12 weeks after implantation ]

3.  Primary:   Safety   [ Time Frame: During 12-week original study and at long-term follow-up of 11 months or longer ]


  Serious Adverse Events


  Other Adverse Events


  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.


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.  


Results Point of Contact:  
Name/Title: David Hodge, Project Manager
Organization: Medtronic Xomed, Inc.
phone: (+1-904) 281-2774
e-mail: david.l.hodge@medtronic.com


Publications:

Responsible Party: Medtronic Xomed, Inc.
ClinicalTrials.gov Identifier: NCT00729781     History of Changes
Other Study ID Numbers: 925
Study First Received: August 5, 2008
Results First Received: August 23, 2011
Last Updated: December 1, 2011
Health Authority: United States: Food and Drug Administration