A Randomized Trial Comparing Routine Use of the ActiValve to Standard Voice Prostheses (NCT07369050) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Randomized Trial Comparing Routine Use of the ActiValve to Standard Voice Prostheses
United States48 participantsStarted 2026-07-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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\*
Exclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and Adverse Events (AEs)
Timeframe: Through study completion; an average of 1 year