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Short-term Clinical Feasibility of the Provox XtraHMEs for Pulmonary Rehabilitation After Total Laryngectomy (N08HME)

This study has been completed.
Sponsor:
Collaborator:
The Netherlands Cancer Institute
Information provided by:
Atos Medical AB
ClinicalTrials.gov Identifier:
NCT00942903
First received: July 20, 2009
Last updated: October 13, 2010
Last verified: October 2010
Results First Received: August 4, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Total Laryngectomy
Intervention: Device: Provox Xtra HME

  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
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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
Provox XtraHME A group oflaryngectomized patients who normally use a Provox HME, converted to Provox XtraHME for a period of 3 weeks

Participant Flow:   Overall Study
    Provox XtraHME  
STARTED     20  
COMPLETED     20  
NOT COMPLETED     0  



  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.
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Reporting Groups
  Description
Provox XtraHME A group oflaryngectomized patients who normally use a Provox HME, converted to Provox XtraHME for a period of 3 weeks

Baseline Measures
    Provox XtraHME  
Number of Participants  
[units: participants]
  20  
Age  
[units: patients]
 
<=18 years     0  
Between 18 and 65 years     10  
>=65 years     10  
Age  
[units: years]
Mean ± Standard Deviation
  66.4  ± 9.07  
Gender  
[units: patients]
 
Female     2  
Male     18  
Region of Enrollment  
[units: patients]
 
Netherlands     20  



  Outcome Measures
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1.  Primary:   Patient Preference for Provox HME or Provox XtraHME   [ Time Frame: 3 weeks ]

2.  Secondary:   Noise at Stoma Occlusion   [ Time Frame: 3 weeks ]


  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. F.J.M. Hilgers
Organization: The Netherlands Cancer Institute
phone: +31-20-5122550
e-mail: f.hilgers@nki.nl


No publications provided


Responsible Party: Corina van As-Brooks, Clinical Affairs Manager, Atos Medical
ClinicalTrials.gov Identifier: NCT00942903     History of Changes
Other Study ID Numbers: UD781_3CHME
Study First Received: July 20, 2009
Results First Received: August 4, 2010
Last Updated: October 13, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands: Medical Ethics Review Committee (METC)