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NCT Number: NCT05036330

ProvoxLife Adoption Trends for Heat-Moisture Exchanger

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Malignant Head and Neck Neoplasm Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clinical evaluation

Other

Undergo speech and swallow evaluation

Other names: Clinical Assessment

Physical Examination

Procedure

Undergo examination of TEP and laryngectomy stoma

Other names: Assessment, General Examination

Quality-of-Life Assessment

Other

Complete questionnaires

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Complete questionnaires

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.

    Time frame: Up to 3 months post-ProvoxLife HME

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Sep 5, 2021
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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