Active — Not RecruitingNot Applicable

ProvoxLife Adoption Trends for Heat-Moisture Exchanger

United States130 participantsStarted 2021-05-21

Plain-language summary

This study examines factors that affect how often patients who have a total laryngectomy use a ProvoxLife heat-moisture exchanger (HME) system to help improve their lung function. ProvoxLife HMEs are single use heat- and moisture exchangers for patients breathing through a tracheostoma. Information from this study may help doctors learn more about factors associated with patterns of use and how often patients use the ProvoxLife HME system.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Adults \>= 18 years of age planned for or status post total laryngectomy * Using or ready for fit of HME system Exclusion Criteria: * Active malignancy if post-total laryngectomy (TL) at the time of enrollment * Unable to complete questionnaires in English language * The primary endpoint derives from a study specific questionnaire, due to limited resources, is only available in English language * Cognitive or other limitations that preclude independent self-care or completion of questionnaires * Cognitive or other limitations that preclude independent self-care or completion of questionnaires will be assessed in the screening interview by the clinical or research team

What they're measuring

To determine clinical and patient factors associated with patterns of use of the ProvoxLife HME system for pulmonary rehabilitation after total laryngectomy.

Timeframe: Up to 3 months post-ProvoxLife HME

Trial details

NCT IDNCT05036330

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-02-02

View on ClinicalTrials.gov More Malignant Head and Neck Neoplasm trials