Clinical trial · Observational
ProvoxLife Adoption Trends for Heat-Moisture Exchanger
ProvoxLife® Adoption Trends for Heat-Moisture Exchanger (HME): The PATH Registry
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Head and Neck Neoplasm | Malignant Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clinical Evaluation | Other | — | UNRESOLVED |
| Physical Examination | Procedure | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational (evaluation, examination, questionnaire)
- description
- 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.
- interventionNames
- Other: Clinical Evaluation
- Procedure: Physical Examination
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
Primary outcomes (1)
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available