LaryngectomyNCT07369050
A Randomized Trial Comparing Routine Use of the ActiValve to Standard Voice Prostheses
A study testing Provox® ActiValve® in people with Laryngectomy, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if regular use of Provox® ActiValve® by patients after a total laryngectomy with TEP can decrease the number of VP device replacements needed annually. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laryngectomy
- What is being tested?
- Provox® ActiValve®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 1 Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥ 18 years of age status post total laryngectomy with tracheoesophageal puncture
- Using or ready for fit of indwelling voice prosthesis
- No evidence of disease (NED) in head and neck
- At least 6 months since cancer treatment
- 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).
Who cannot join
- History of recurrent leak around voice prosthesis and/or severely enlarged puncture (within last 12 months)
- History of recurrent VP extrusion (within last 12 months)
- Currently using specialty Activalve voice prosthesis as a "problem solver" due to poor device life as defined in the Instructions for Use (IFU)
- History of recurrent early VP leak within 4 to 8 weeks of fit (within last 12 months)
- Active malignancy in head and neck and/or chest at the time of enrollment
- Receiving or planned for head and neck radiation therapy (RT) at the time of enrollment
Show all 9Show fewer
- Receiving regular magnetic resonance imaging (MRI) for cancer surveillance or other medical reasons
- Planned regular VP exchanges at outside facility within next 12 months
- History of gastric pull-up reconstruction
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77090
Katherine A Hutcheson, PHD, 713-792-6513, karnold@mdanderson.org
Katherine A Hutcheson, PHD
About this study
Official title: Is the Provox ActiValve Only a Problem Solver? A Randomized Trial Comparing Routine Use of the ActiValve to Standard Voice Prostheses After Total Laryngectomy With Tracheoesophageal Puncture
The goal of this clinical research study is to learn if regular use of Provox® ActiValve® by patients after a total laryngectomy with TEP can decrease the number of VP device replacements needed annually.
Read the detailed description
Primary Objective:
To determine whether routine use of Provox® ActiValve® voice prosthesis decreases annual number of clinical procedures to exchange VP in indwelling voice prosthesis users after total laryngectomy with TEP.
Secondary Objectives:
- To compare outcomes, adverse events, and costs associated with routine use of Provox® ActiValve® (experimental) versus standard indwelling voice prostheses (comparator)
- To compare outcomes, adverse events, and costs associated with prophylactic exchange of Provox® ActiValve® versus routine use of Provox® ActiValve® (experimental) or standard indwelling voice prostheses (comparator)
Exploratory objectives:
- To explore relationships between clinicodemographic features and device/TEP function
- To explore relationships between pharyngoesophageal pressures via manometry and device/TEP function
- To explore relationships between oral/tracheal microbiome and device/TEP function
- To describe novel use of prophylactic exchange of Provox® ActiValve®
- Conditions
- Laryngectomy
- Being tested
- Provox® ActiValve®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provox® ActiValve®Device
Participants experiencing early leakage with previous voice prostheses (device life less than 4-8 weeks). The device reduced the need for frequent replacements in a majority of users but not in all"7. The Light valve strength will be used in this trial.
| Study group | Role | What they receive |
|---|---|---|
| Routine "as needed" exchange with Provox ActiValve | Experimental | Participants randomized to Arm 1 will receive a Provox® ActiValve® at the first VP replacement after randomization Receives: Device: Provox® ActiValve® |
| Standard indwelling VP with optional cross-over to Provox ActiValve | Experimental | Participants randomized into Arm 2 will receive their standard VP exchanges on "as needed" basis through the 12-month study period. Receives: Device: Provox® ActiValve® |
| Prophylactic Provox ActiValve exchange | Experimental | Participants randomized to Arm 3 will receive a Provox® ActiValve® at the first VP replacement after randomization and prophylactic exchange will target replacement of the device between 9 months +/-1 month after fit. Receives: Device: Provox® ActiValve® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaryngectomyStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katherine A Hutcheson, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07369050
- Sponsor's protocol ID
- 2025-1610
- Other IDs
- NCI-2026-00404
- Status last verified
- Sep 2026
- First submitted
- 23 Jan 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Provox ActiValve Only a Problem Solver? A Randomized Trial Comparing Routine Use of the ActiValve to Standard Voice Prostheses After Total Laryngectomy With Tracheoesophageal Puncture
- ClinicalTrials.gov ID
- NCT07369050
- Acronym / sponsor ID
- 2025-1610
- Conditions
- Laryngectomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if regular use of Provox® ActiValve® by patients after a total laryngectomy with TEP can decrease the number of VP device replacements needed annually.
Detailed description
Primary Objective:
To determine whether routine use of Provox® ActiValve® voice prosthesis decreases annual number of clinical procedures to exchange VP in indwelling voice prosthesis users after total laryngectomy with TEP.
Secondary Objectives:
- To compare outcomes, adverse events, and costs associated with routine use of Provox® ActiValve® (experimental) versus standard indwelling voice prostheses (comparator)
- To compare outcomes, adverse events, and costs associated with prophylactic exchange of Provox® ActiValve® versus routine use of Provox® ActiValve® (experimental) or standard indwelling voice prostheses (comparator)
Exploratory objectives:
- To explore relationships between clinicodemographic features and device/TEP function
- To explore relationships between pharyngoesophageal pressures via manometry and device/TEP function
- To explore relationships between oral/tracheal microbiome and device/TEP function
- To describe novel use of prophylactic exchange of Provox® ActiValve®
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Routine "as needed" exchange with Provox ActiValve | Experimental | Device: Provox® ActiValve®Participants randomized to Arm 1 will receive a Provox® ActiValve® at the first VP replacement after randomization |
| Standard indwelling VP with optional cross-over to Provox ActiValve | Experimental | Device: Provox® ActiValve®Participants randomized into Arm 2 will receive their standard VP exchanges on "as needed" basis through the 12-month study period. |
| Prophylactic Provox ActiValve exchange | Experimental | Device: Provox® ActiValve®Participants randomized to Arm 3 will receive a Provox® ActiValve® at the first VP replacement after randomization and prophylactic exchange will target replacement of the device between 9 months +/-1 month after fit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults ≥ 18 years of age status post total laryngectomy with tracheoesophageal puncture
- Using or ready for fit of indwelling voice prosthesis
- No evidence of disease (NED) in head and neck
- At least 6 months since cancer treatment
- TEP tract length 4.5 to 12.5mm at time of enrollment*
Key exclusion criteria (9 listed)
- History of recurrent leak around voice prosthesis and/or severely enlarged puncture (within last 12 months)
- History of recurrent VP extrusion (within last 12 months)
- Currently using specialty Activalve voice prosthesis as a "problem solver" due to poor device life as defined in the Instructions for Use (IFU)
- History of recurrent early VP leak within 4 to 8 weeks of fit (within last 12 months)
- Active malignancy in head and neck and/or chest at the time of enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Provox® ActiValve®Participants experiencing early leakage with previous voice prostheses (device life less than 4-8 weeks). The device reduced the need for frequent replacements in a majority of users but not in all"7. The Light valve strength will be used in this trial. | Device | Prophylactic Provox ActiValve exchange, Routine "as needed" exchange with Provox ActiValve, Standard indwelling VP with optional cross-over to Provox ActiValve |
Primary outcome
Safety and Adverse Events (AEs)
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katherine A Hutcheson, PHD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provox® ActiValve® in people with Laryngectomy, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katherine A Hutcheson, PHD ((713) 792-6513, karnold@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.