NCT05036330

ProvoxLife Adoption Trends for Heat-Moisture Exchanger

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 130 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malignant Head and Neck Neoplasm

Interventions

Type	Name	Description
OTHER	Clinical Evaluation	Undergo speech and swallow evaluation
PROCEDURE	Physical Examination	Undergo examination of TEP and laryngectomy stoma
OTHER	Quality-of-Life Assessment	Complete questionnaires
OTHER	Questionnaire Administration	Complete questionnaires

Timeline

• Start date: 2021-05-21
• Primary completion: 2027-02-02
• Completion: 2027-02-02
• First posted: 2021-09-05
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States