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Not yet recruiting NCT07369050

A Randomized Trial Comparing Routine Use of the ActiValve to Standard Voice Prostheses

No phase Interventional Laryngectomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Provox® ActiValve®.
Who it may be relevant to
Registry conditions: Laryngectomy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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:

1. To compare outcomes, adverse events, and costs associated with routine use of Provox® ActiValve® (experimental) versus standard indwelling voice prostheses (comparator) 2. 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:

1. To explore relationships between clinicodemographic features and device/TEP function 2. To explore relationships between pharyngoesophageal pressures via manometry and device/TEP function 3. To explore relationships between oral/tracheal microbiome and device/TEP function 4. To describe novel use of prophylactic exchange of Provox® ActiValve®

Interventions

  • Device 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.

Primary outcome measures

  • Safety and Adverse Events (AEs) [Time frame: Through study completion; an average of 1 year]

Eligibility criteria

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\*
  • 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

  • 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
  • History of gastric pull-up reconstruction

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • The University of Texas M. D. Anderson Cancer Center — Houston

Identifiers

NCT: NCT07369050 · 2025-1610 · NCI-2026-00404

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗