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New voice valve could cut down on annoying replacements for throat cancer survivors

NCT ID NCT07369050

Disease control 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 03, 2026 · Updated 5 times

Summary

This study tests whether using the Provox ActiValve voice prosthesis as a first choice can reduce the number of times the device needs to be replaced each year in people who have had their voice box removed (laryngectomy) and have a tracheoesophageal puncture (TEP). The trial will enroll 48 adults who are at least 6 months past cancer treatment and have no signs of cancer. Researchers will compare the ActiValve to standard voice prostheses to see if it leads to fewer replacements and fewer complications.

What this could mean

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

Active substance
Provox® ActiValve® voice prosthesis device
What this could lead to
If it works, this could mean fewer device replacements and less hassle for people who have had a laryngectomy.
What could go wrong
This is a small, early-stage trial with only 48 participants, so results may not apply to everyone. The device may not reduce replacements for all users.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 48 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Sep 2030

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.

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: 1. Adults ≥ 18 years of age status post total laryngectomy with tracheoesophageal puncture 2. Using or ready for fit of indwelling voice prosthesis 3. No evidence of disease (NED) in head and neck 4. At least 6 months since cancer treatment 5. TEP tract length 4.5 to 12.5mm at time of enrollment\* * The range reflects the available device sizes for the Provox® ActiValve® . Eligibility is determined by confirming that the patient is appropriately fitted with a VP within this size range, based on the site's standard clinical practice (e.g. appearance/fit and/or depth gauge). Exclusion Criteria: 1. History of recurrent leak around voice prosthesis and/or severely enlarged puncture (within last 12 months) 2. History of recurrent VP extrusion (within last 12 months) 3. Currently using specialty Activalve voice prosthesis as a "problem solver" due to poor device life as defined in the Instructions for Use (IFU) 4. History of recurrent early VP leak within 4 to 8 weeks of fit (within last 12 months) 5. Active malignancy in head and neck and/or chest at the time of enrollment 6. Receiving or planned for head and neck radiation therapy (RT) at the time of enrollment 7. Receiving regular magnetic resonance imaging (MRI) for cancer surveillance or other medical reasons 8. Planned regular VP exchanges at outside facility within next 12 months 9. History of gastric pull-up reconstruction

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Conditions

The condition(s) this trial relates to.

laryngeal carcinoma

As listed by the trial registrant

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

Laryngectomy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The University of Texas M. D. Anderson Cancer Center

    Houston, Texas, 77090, United States

More trials for these conditions

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