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NCT05036330 Clinical Trial

ProvoxLife Adoption Trends for Heat-Moisture Exchanger

Malignant Head and Neck Neoplasm Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05036330
Other study ID # 2020-1114
Secondary ID NCI-2021-0878420
Status Active, not recruiting
Phase
First received
Last updated
Start date May 21, 2021
Est. completion date February 2, 2027

Study information
Verified date April 2024
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 130
Est. completion date February 2, 2027
Est. primary completion date February 2, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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
• Questionnaire Administration
Complete questionnaires

Locations
Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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