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Breathing device use after throat surgery under the microscope

NCT ID NCT05036330

Knowledge-focused Sponsor: M.D. Anderson Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tracks 130 adults who have had their voice box removed (laryngectomy) to see how often they use a special breathing filter called a heat-moisture exchanger (HME). Researchers at MD Anderson Cancer Center want to learn what factors—like patient habits or clinical follow-up—affect consistent use. Participants will undergo speech and swallow evaluations, physical exams, and complete questionnaires. The goal is to improve lung health and quality of life for future patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ProvoxLife heat-moisture exchanger (HME) system
What this could lead to
If successful, this study could help doctors understand why some patients use their HME more consistently, leading to better support and improved lung health after laryngectomy.
What could go wrong
This is an observational registry, not a treatment trial. It will not test a new therapy or cure, and results may not apply to all patients or settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

130 people

The number who actually took part.

Started

May 2021

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients using or planning to use HME as part of standard care

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

head and neck cancer Head and Neck Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Malignant head and neck neoplasm

Contacts and locations

Locations

  • M D Anderson Cancer Center

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.