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COMPLETEDNANCT04943731

Day/Night Regimen With Provox Life Heat and Moisture Exchangers

Purpose and Aim: This research is about patients who have had a total laryngectomy, trialing a new range of Heat and Moisture Exchangers (HMEs) - referred to as the "Provox Life™ range of HMEs". The m...

Lead sponsor: Atos Medical AB•3 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Atos Medical AB

Collaborators

Princess Alexandra Hospital, Brisbane, Australia
Royal Brisbane and Women's Hospital
Prince of Wales Hospital, Sydney

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Total laryngectomy, irrespective of pharynx reconstruction method
•18 years or older
•HME user
•Longer than 3 months after total laryngectomy
•Longer than 6 weeks after postoperative radiotherapy

Exclusion Criteria

•Current day/night routine with Provox Luna
•Daily use of Provox Micron HMEF
•Medical problems prohibiting the use of HME
•Active recurrent or metastatic disease (medical deterioration)
•Recent pulmonary infections/unstable pulmonary condition
•Reduced mobility of arms and/or hands, unable to insert or remove an HME
•Unable to understand the Participant Information and/or unable to give Informed Consent
•Insufficient cognitive ability to manage HME or adhesive use

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: May 15, 2023Terms

Trial snapshot

StatusCOMPLETED

PhaseNA

Enrollment48

Start dateJul 2021

Last updatedMay 15, 2023

Condition

Locations shown

Prince of Wales Hospital, NSW

Sydney, New South Wales

Royal Brisbane and Women's Hospital

Herston, Queensland

Princess Alexandra Hospital

Woolloongabba, Queensland

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 15, 2023Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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