ProvoxLife Adoption Trends for Heat-Moisture Exchanger
ProvoxLife® Adoption Trends for Heat-Moisture Exchanger (HME): The PATH Registry
2 other identifiers
observational
130
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 21, 2021
CompletedFirst Submitted
Initial submission to the registry
August 25, 2021
CompletedFirst Posted
Study publicly available on registry
September 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 2, 2027
April 15, 2026
April 1, 2026
5.7 years
August 25, 2021
April 10, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
To determine clinical and patient factors associated with patterns of use of the ProvoxLife HME system for pulmonary rehabilitation after total laryngectomy.
Up to 3 months post-ProvoxLife HME
Study Arms (1)
Observational (evaluation, examination, questionnaire)
Patients undergo speech and swallow evaluation by speech pathologist or study staff member and examination of TEP and laryngectomy stoma. Patients also complete questionnaires over 30 minutes about use the ProvoxLife HME system, symptoms, ability to communicate, exercise and physical activity levels, and quality of life at baseline and 3 months post-ProvoxLife.
Interventions
Undergo speech and swallow evaluation
Undergo examination of TEP and laryngectomy stoma
Complete questionnaires
Complete questionnaires
Eligibility Criteria
Patients using or planning to use HME as part of standard care
You may qualify if:
- Adults \>= 18 years of age planned for or status post total laryngectomy
- Using or ready for fit of HME system
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katherine A Hutcheson
M.D. Anderson Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2021
First Posted
September 5, 2021
Study Start
May 21, 2021
Primary Completion (Estimated)
February 2, 2027
Study Completion (Estimated)
February 2, 2027
Last Updated
April 15, 2026
Record last verified: 2026-04