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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:
ClinicalTrials.gov Identifier:
NCT00942903
First Posted: July 21, 2009
Last Update Posted: October 22, 2010
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.
Collaborator:
The Netherlands Cancer Institute
Information provided by:
Atos Medical AB
  Purpose
This study is a short term feasibility study that aims to investigate patient satisfaction with and performance of new Provox Xtra HME in 20 laryngectomized patients. Aspects that are considered are for example performance for stoma occlusion, speaking, breathing, appearance, compliance, and short-term impact on pulmonary symptoms.

Condition Intervention Phase
Total Laryngectomy Device: Provox Xtra HME Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study. Short-term Feasibility of the Next Generation Provox HMEs for Pulmonary Rehabilitation After Total Laryngectomy

Resource links provided by NLM:


Further study details as provided by Atos Medical AB:

Primary Outcome Measures:
  • Patient Preference for Provox HME or Provox XtraHME [ Time Frame: 3 weeks ]
    the patient preference is based on a structured questionnaire on several aspects regarding the use of the new Provox XtraHME in comparison with the Provox HME.


Secondary Outcome Measures:
  • Noise at Stoma Occlusion [ Time Frame: 3 weeks ]
    the number of patients presenting any hissing, whistling, or plopping noises before, during, or after stoma occlusion while using the new XtraHME


Enrollment: 20
Study Start Date: July 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Compliant HME users
Laryngectomized patients who are currently compliant (24/7) users of a Provox HME
Device: Provox Xtra HME
Heat and Moisture Exchanger for pulmonary Rehabilitation after total laryngectomy
Other Names:
  • Heat and Moisture Exchanger
  • Provox HME

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • total laryngectomy
  • compliant Provox HME user (24/7 use)

Exclusion Criteria:

  • current medical problems that might influence HME use
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00942903


Locations
Netherlands
Netherlands Cancer Institute
Amsterdam, Noord Holland, Netherlands, 1066 CX
Sponsors and Collaborators
Atos Medical AB
The Netherlands Cancer Institute
Investigators
Principal Investigator: Frans JM Hilgers, MD The Netherlands Cancer Institute
  More Information

Responsible Party: Corina van As-Brooks, Clinical Affairs Manager, Atos Medical
ClinicalTrials.gov Identifier: NCT00942903     History of Changes
Other Study ID Numbers: UD781_3CHME
First Submitted: July 20, 2009
First Posted: July 21, 2009
Results First Submitted: August 4, 2010
Results First Posted: August 30, 2010
Last Update Posted: October 22, 2010
Last Verified: October 2010

Keywords provided by Atos Medical AB:
HME
Provox
voice prosthesis
laryngectomy