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Long Term Use of the Provox Vega 22.5

This study has been completed.
Sponsor:
Collaborator:
The Netherlands Cancer Institute
Information provided by (Responsible Party):
Atos Medical AB
ClinicalTrials.gov Identifier:
NCT00884910
First received: April 20, 2009
Last updated: July 12, 2012
Last verified: July 2012
Results First Received: August 2, 2010  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Condition: Total Laryngectomy
Intervention: Device: Provox Vega voice prosthesis 22.5 Fr

  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
Patients were recruited by the Netherlands Cancer Institute

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
Provox Vega 22.5 The newly developed Provox Vega voice prosthesis, with an outer diameter of 22.5 French, was placed in the tracheoesophageal puncture of laryngectomized patients. Before the study, the patients were using another voice prosthesis (Provox2). The Provox2 is the predecessor of the Provox Vega. At the start of the study the patients' Provox2 voice prosthesis was removed and replaced with the Provox Vega 22.5.

Participant Flow:   Overall Study
    Provox Vega 22.5  
STARTED     33  
COMPLETED     32 [1]
NOT COMPLETED     1  
[1] patient diagnosed with primary pulmonary tumor during 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
Provox Vega 22.5 The newly developed Provox Vega voice prosthesis, with an outer diameter of 22.5 French, was placed in the tracheoesophageal puncture of laryngectomized patients. Before the study, the patients were using another voice prosthesis (Provox2). The Provox2 is the predecessor of the Provox Vega. At the start of the study the patients' Provox2 voice prosthesis was removed and replaced with the Provox Vega 22.5.

Baseline Measures
    Provox Vega 22.5  
Number of Participants  
[units: participants]
  33  
Age  
[units: patients]
 
<=18 years     0  
Between 18 and 65 years     15  
>=65 years     18  
Age  
[units: years]
Mean ± Standard Deviation
  66.42  ± 12.6  
Gender  
[units: patients]
 
Female     1  
Male     32  
Region of Enrollment  
[units: patients]
 
Netherlands     33  



  Outcome Measures
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1.  Primary:   Patient Preference   [ Time Frame: 3 months post insertion, or at end of device life (whichever comes sooner) ]

2.  Secondary:   Device Life Time   [ Time Frame: 6 months ]


  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 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: Prof Dr FJM Hilgers
Organization: Netherlands Cancer Institute
phone: +31 20 512 2550
e-mail: f.hilgers@nki.nl


No publications provided


Responsible Party: Atos Medical AB
ClinicalTrials.gov Identifier: NCT00884910     History of Changes
Other Study ID Numbers: N07VEGA Amendment 22.5
Study First Received: April 20, 2009
Results First Received: August 2, 2010
Last Updated: July 12, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)