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

Total Laryngectomy Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Total Laryngectomy

Clinical Trial Details

NCT number	NCT00942903
Study type	Interventional
Source	Atos Medical AB
Contact
Status	Completed
Phase	Phase 1
Start date	July 2009
Completion date	August 2009

View Details

See also
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Completed	`NCT00743262` - Short-term Clinical Feasibility of the New Provox Vega 22.5 Voice Prosthesis	Phase 1/Phase 2