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OpenTrials
Completed

NCT Number: NCT00942903

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

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.

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Key information

Conditions

Total Laryngectomy

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Netherlands Cancer Institute

Amsterdam, North Holland, 1066 CX, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • current medical problems that might influence HME use

Treatment and study plan

Provox Xtra HME

Device

Heat and Moisture Exchanger for pulmonary Rehabilitation after total laryngectomy

Other names: Heat and Moisture Exchanger, Provox HME

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Atos Medical AB

Industry

Collaborators

  • The Netherlands Cancer Institute

Registry information

Official study title

Phase 1 Study. Short-term Feasibility of the Next Generation Provox HMEs for Pulmonary Rehabilitation After Total Laryngectomy

Acronym: N08HME

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jul 21, 2009
Registry last updated
Oct 22, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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