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 range18 Years

SexALL

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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
✕. Receiving or planned for head and neck radiation therapy (RT) at the time of enrollment
✕. Receiving regular magnetic resonance imaging (MRI) for cancer surveillance or other medical reasons
✕. Planned regular VP exchanges at outside facility within next 12 months

What they're measuring

Safety and Adverse Events (AEs)

Timeframe: Through study completion; an average of 1 year

Trial details

NCT IDNCT07369050

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-09-01

Contact for this trial

Katherine A Hutcheson, PHD

(713) 792-6513 karnold@mdanderson.org

View on ClinicalTrials.gov More Laryngectomy trials