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
  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: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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)

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

ClinicalTrials.gov processed this record on July 23, 2014