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

NCT ID: NCT00942903

Last Updated: 2010-10-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2009-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Total Laryngectomy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Compliant HME users

Laryngectomized patients who are currently compliant (24/7) users of a Provox HME

Group Type EXPERIMENTAL

Provox Xtra HME

Intervention Type DEVICE

Heat and Moisture Exchanger for pulmonary Rehabilitation after total laryngectomy

Interventions

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Provox Xtra HME

Heat and Moisture Exchanger for pulmonary Rehabilitation after total laryngectomy

Intervention Type DEVICE

Other Intervention Names

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Heat and Moisture Exchanger Provox HME

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* current medical problems that might influence HME use
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Netherlands Cancer Institute

OTHER

Sponsor Role collaborator

Atos Medical AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Atos Medical

Principal Investigators

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Frans JM Hilgers, MD

Role: PRINCIPAL_INVESTIGATOR

The Netherlands Cancer Institute

Locations

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Netherlands Cancer Institute

Amsterdam, North Holland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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UD781_3CHME

Identifier Type: -

Identifier Source: org_study_id