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

Atos Medical

Status and phase: Completed; Phase 1

Conditions: Total Laryngectomy

Treatments: Device: Provox Xtra HME

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00942903

UD781_3CHME

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• current medical problems that might influence HME use

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Compliant HME users

Experimental group

Description:

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

Treatment:

Device: Provox Xtra HME