ProvoxLife Adoption Trends for Heat-Moisture Exchanger

ProvoxLife® Adoption Trends for Heat-Moisture Exchanger (HME): The PATH Registry

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05036330

Enrollment

130

Registered

2021-09-05

Start date

2021-05-21

Completion date

2027-02-02

Last updated

2026-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Head and Neck Neoplasm

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.

Detailed description

PRIMARY OBJECTIVE: I. To determine clinical and patient factors associated with patterns of use of the ProvoxLife HME system for pulmonary rehabilitation after total laryngectomy. SECONDARY OBJECTIVES: I. To explore outcomes associated with patterns of ProvoxLife HME system. II. To explore factors associated with post-laryngectomy outcomes. OUTLINE: Patients undergo speech and swallow evaluation by speech pathologist or study staff member and examination of tracheoesophageal puncture (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

OTHERClinical Evaluation

Undergo speech and swallow evaluation

PROCEDUREPhysical Examination

Undergo examination of TEP and laryngectomy stoma

OTHERQuality-of-Life Assessment

Complete questionnaires

OTHERQuestionnaire Administration

Complete questionnaires

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORKatherine A Hutcheson

M.D. Anderson Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 16, 2026