Long Term Effects of Heat and Moisture Exchangers (HMEs)
NCT ID: NCT06084611
Last Updated: 2025-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2024-03-26
2025-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Provox Life HME
Use of Provox Life HMEs and attachment
Provox Life
Compliant use of Provox Life HMEs
Control - No HME
Control group is current standard of Care in Brazil, which is not using an HME
No interventions assigned to this group
Interventions
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Provox Life
Compliant use of Provox Life HMEs
Eligibility Criteria
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Inclusion Criteria
* 18 years or older
* Longer than 3 months after total laryngectomy
* Longer than 6 weeks after postoperative radiotherapy
Exclusion Criteria
* Medical problems prohibiting the use of HME
* Active recurrent or metastatic disease (medical deterioration)
* Recent pulmonary infections/unstable pulmonary condition
* Insufficient physical, cognitive, or mental ability required to attach, remove or operate the devices themselves
* Low tidal volumes
* Unable to understand the Participant Information and/or unable to give Informed Consent
18 Years
ALL
No
Sponsors
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Instituto de Cancer Dr Arnaldo
UNKNOWN
Atos Medical AB
INDUSTRY
Responsible Party
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Locations
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Instituto de Cancer Dr. Arnaldo
São Paulo, , Brazil
Countries
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Other Identifiers
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PL_Brazil
Identifier Type: -
Identifier Source: org_study_id
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